ACTIVE_NOT_RECRUITING

Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer.

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority clinical study in women aged 35 to 42 years. This study will investigate the safety and efficacy of Progesterone-IBSA to support euploid embryo blastocyst implantation and early pregnancy after frozen embryo transfer (FET) in a modified natural cycle as a treatment for infertile women. Subjects will be randomized to receive either active Progesterone-IBSA or Crinone 8% for luteal and early pregnancy support and these two groups will be compared.

Official Title

A Multicenter, Randomized, Controlled, Double-blind, Double-dummy Study to Evaluate the Safety and Efficacy of Subcutaneous Progesterone Compared to Vaginal Progesterone for Luteal Phase Supplementation in Modified Natural Frozen Euploid Blastocyst Transfer.

Quick Facts

Study Start:2022-10-12

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04549116

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years to 42 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* subject has given written informed consent; * Premenopausal women 35 to 42 years of age at the time of consent (at least 35 \[including day of birthday\] and no more than 42 \[up to the day before their 43rd birthday\]); * Valid indication for IVF treatment (i.e. history of infertility according to ASRM definition, single women or same-sex couples); * Consistent, regular spontaneous ovulatory menstrual cycle with normal length (24-38 days included); * Body mass index (BMI) \< 38 kg/m2; * Subject with at least one euploid frozen blastocyst from a previous IVF treatment cycle; * Less than 3 previous consecutive euploid blastocyst transfers without a life birth; * Baseline Follicle Stimulating Hormone (FSH) \< 15 mIU/mL, and Anti Muellerian Hormone (AMH) \>0.7 ng/mL (within 6 months from screening for subjects requiring a stimulation cycle to obtain a euploid embryo); and Estradiol (E2) \< 90 pg/mL and Progesterone (P4)\< 1.5 ng/mL at Visit 1 (for all subjects); * Semen used during IVF(for subjects requiring a stimulation cycle to obtain a euploid embryo) was produced by ejaculation (not surgically derived sperm) from either the partner or from a sperm donor. Donor must be 18-40 years of age at the time of collection and compliant with 21 Code of Regulations (CFR) section 1271 Subpart C; * Hysterosalpingography, hysteroscopy, 3D ultrasound or sonohysterogram documenting a normal uterine cavity within the last year; * Normal cervical cytology/High Risk human papillomavirus (HPV) testing per American College of Obstetricians and Gynecologists guidelines.	* Oligo or anovulation (spontaneous menses \> 39 days apart); * Breastfeeding or Pregnancy; * Contraindication to pregnancy (i.e. an active, uncontrolled clinically significant medical condition or abnormality of the sexual organs determined by the provider); * Known family history of major congenital anomalies; * Moderate to severe current endometriosis (stage 3 or 4); * Presence of a unilateral or bilateral hydrosalpinx that communicates with the uterus, that has not been ligated prior to treatment; * Recurrent pregnancy loss (RPL) as defined by the American Society of Reproductive Medicine (ASRM) as two or more consecutive failed clinical pregnancies; * Presence of a submucosal or intramural fibroid \> 4 cm which distorts the uterine cavity or are \> 5 cm in diameter; * Untreated uterine pathology that could impair embryo implantation (i.e. scarring/Asherman's syndrome or intra uterine polyps \> 1 cm in size); * Type 1 or 2 diabetes mellitus based on American Diabetes Association (ADA) criteria3; * Uncontrolled adrenal or thyroid dysfunction; * History of conditions (i.e. toxic shock syndrome) that would contraindicate use of a vaginal progesterone product; * Subjects with hepatic impairment (liver function tests \> 2x upper limit of normal); * Subjects with renal impairment (estimated creatinine clearance \<60 mL/min/1.73 m2); * History of an active or treated autoimmune disease (i.e. systemic lupus erythematosus); * History of arterial disease (i.e. Prior or active thrombophlebitis, thromboembolic disorder or known thrombophilia); * Neoplasias (current) or history of neoplasia that may be responsive to progesterone; * High grade cervical dysplasia; * Undiagnosed vaginal bleeding (i.e. at the time of screening); * Use of donor eggs or plans to use a gestational carrier; * Use of endometrial receptivity array (ERA) test to postpone or anticipate the embryo transfer (ET) day; * Use of epididymal, testicular , electro-ejaculated or chemotherapy exposed sperm; * Known allergy to progesterone preparations or their excipients; * Current dependence on alcohol, tobacco (must not be smoking/using tobacco x 2 months before the study) or drugs or psychotropic medications labeled as Pregnancy Categories D and X; * Use of concomitant medications within 1 month previous the start of the FET cycle preparation up to gestational week 12 that might interfere with the study evaluation (use of insulin sensitizing agents, vaginal medications/preparations, any drugs for luteal support other than those specified in the protocol, aspirin, any hormonal treatment, with the exception of levothyroxine); * Participation in a concurrent clinical trial or in another investigational drug trial within the past 2 months-

Inclusion Criteria

Exclusion Criteria

* subject has given written informed consent;
* Premenopausal women 35 to 42 years of age at the time of consent (at least 35 \[including day of birthday\] and no more than 42 \[up to the day before their 43rd birthday\]);
* Valid indication for IVF treatment (i.e. history of infertility according to ASRM definition, single women or same-sex couples);
* Consistent, regular spontaneous ovulatory menstrual cycle with normal length (24-38 days included);
* Body mass index (BMI) \< 38 kg/m2;
* Subject with at least one euploid frozen blastocyst from a previous IVF treatment cycle;
* Less than 3 previous consecutive euploid blastocyst transfers without a life birth;
* Baseline Follicle Stimulating Hormone (FSH) \< 15 mIU/mL, and Anti Muellerian Hormone (AMH) \>0.7 ng/mL (within 6 months from screening for subjects requiring a stimulation cycle to obtain a euploid embryo); and Estradiol (E2) \< 90 pg/mL and Progesterone (P4)\< 1.5 ng/mL at Visit 1 (for all subjects);
* Semen used during IVF(for subjects requiring a stimulation cycle to obtain a euploid embryo) was produced by ejaculation (not surgically derived sperm) from either the partner or from a sperm donor. Donor must be 18-40 years of age at the time of collection and compliant with 21 Code of Regulations (CFR) section 1271 Subpart C;
* Hysterosalpingography, hysteroscopy, 3D ultrasound or sonohysterogram documenting a normal uterine cavity within the last year;
* Normal cervical cytology/High Risk human papillomavirus (HPV) testing per American College of Obstetricians and Gynecologists guidelines.

* Oligo or anovulation (spontaneous menses \> 39 days apart);
* Breastfeeding or Pregnancy;
* Contraindication to pregnancy (i.e. an active, uncontrolled clinically significant medical condition or abnormality of the sexual organs determined by the provider);
* Known family history of major congenital anomalies;
* Moderate to severe current endometriosis (stage 3 or 4);
* Presence of a unilateral or bilateral hydrosalpinx that communicates with the uterus, that has not been ligated prior to treatment;
* Recurrent pregnancy loss (RPL) as defined by the American Society of Reproductive Medicine (ASRM) as two or more consecutive failed clinical pregnancies;
* Presence of a submucosal or intramural fibroid \> 4 cm which distorts the uterine cavity or are \> 5 cm in diameter;
* Untreated uterine pathology that could impair embryo implantation (i.e. scarring/Asherman's syndrome or intra uterine polyps \> 1 cm in size);
* Type 1 or 2 diabetes mellitus based on American Diabetes Association (ADA) criteria3;
* Uncontrolled adrenal or thyroid dysfunction;
* History of conditions (i.e. toxic shock syndrome) that would contraindicate use of a vaginal progesterone product;
* Subjects with hepatic impairment (liver function tests \> 2x upper limit of normal);
* Subjects with renal impairment (estimated creatinine clearance \<60 mL/min/1.73 m2);
* History of an active or treated autoimmune disease (i.e. systemic lupus erythematosus);
* History of arterial disease (i.e. Prior or active thrombophlebitis, thromboembolic disorder or known thrombophilia);
* Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
* High grade cervical dysplasia;
* Undiagnosed vaginal bleeding (i.e. at the time of screening);
* Use of donor eggs or plans to use a gestational carrier;
* Use of endometrial receptivity array (ERA) test to postpone or anticipate the embryo transfer (ET) day;
* Use of epididymal, testicular , electro-ejaculated or chemotherapy exposed sperm;
* Known allergy to progesterone preparations or their excipients;
* Current dependence on alcohol, tobacco (must not be smoking/using tobacco x 2 months before the study) or drugs or psychotropic medications labeled as Pregnancy Categories D and X;
* Use of concomitant medications within 1 month previous the start of the FET cycle preparation up to gestational week 12 that might interfere with the study evaluation (use of insulin sensitizing agents, vaginal medications/preparations, any drugs for luteal support other than those specified in the protocol, aspirin, any hormonal treatment, with the exception of levothyroxine);
* Participation in a concurrent clinical trial or in another investigational drug trial within the past 2 months-

Contacts and Locations

Study Locations (Sites)

The Fertility Treatment Center, LLC

Tempe, Arizona, 85284

United States

HRC Fertility

Encino, California, 91436

United States

Kindbody

Los Angeles, California, 90067

United States

San Diego Fertility

San Diego, California, 92130

United States

Spring Fertility

San Francisco, California, 94109

United States

Illume Fertility

Norwalk, Connecticut, 06851

United States

Reproductive Associates of Delaware

Newark, Delaware, 19713

United States

Women's Medical Research Group, LLC

Clearwater, Florida, 33759

United States

IVF Florida Reproductive Associates

Margate, Florida, 33063

United States

The IVF Center

Winter Park, Florida, 32792

United States

InVia Fertility Specialists, PLLP

Hoffman Estates, Illinois, 60169

United States

Johns Hopkins Fertility Center

Lutherville, Maryland, 21093

United States

University Reproductive Associates, PC

Hasbrouck Heights, New Jersey, 07604

United States

Reproductive Endocrinology Associates of Charlotte

Charlotte, North Carolina, 28207

United States

Carolina Conceptions

Raleigh, North Carolina, 27607

United States

Institute for Reproductive Health

Cincinnati, Ohio, 45209

United States

Main Line Fertility

Bryn Mawr, Pennsylvania, 19010

United States

Shady Grove Fertility

Chesterbrook, Pennsylvania, 19087

United States

Care Fertility

Bedford, Texas, 76022

United States

Aspire Houston Fertility Institute

Houston, Texas, 77063

United States

Center of Reproductive Medicine, LLC., Shady Grove Fertility

Webster, Texas, 77598

United States

Utah Fertility Center, PC

Pleasant Grove, Utah, 84062

United States

Collaborators and Investigators

Sponsor: IBSA Institut Biochimique SA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-12

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2022-10-12

Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

Frozen embryo transfer

Additional Relevant MeSH Terms

Infertility