RECRUITING

The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System

Conditions

Polycystic Ovary Syndrome Infertility, Female PCOS Infertility related to PCOS Ovulation restoration

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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

A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue under Ultrasound Guidance in Women with Infertility due to Polycystic Ovary Syndrome

Official Title

A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue Under Ultrasound Guidance in Women With Infertility Due to Polycystic Ovary Syndrome

Quick Facts

Study Start:2024-03-25

Study Completion:2028-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06206746

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:18 Years to 40 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Age ≥ 18 to ≤ 40 years 2. Infertility associated with oligo- or anovulation, AND EITHER: 2.1 Ultrasonographic evidence of PCOS (ovarian volume ≥ 10 mL and/or ovarian antral follicle count per ovary ≥ 20) OR 2.2 Evidence of hyperandrogenemia: either clinical (hirsutism defined as modified Ferriman-Gallwey (mFG) level ≥ 4-6 depending on ethnicity) or biochemical (raised serum concentration of androgens, testosterone ≥ 2.5 nmol/L, or FAI \> 4) 3. At least one ovary with ovarian volume ≥ 10.0 mL and neither ovary \> 23.0 mL 4. Ovarian accessibility: determined by ability to bring transvaginal ultrasound transducer into close proximity to at least one ovary. (Note: In the situation where only one ovary is appropriately sized according to the preceding criterion, then this requirement applies to the qualifying ovary.) 5. At least one patent fallopian tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years 6. Has not responded to first-line ovulation induction treatment or is contraindicated for, or declines, such treatment 7. Currently seeking immediate fertility 8. Willing to comply with Clinical Investigation Plan-specified follow-up evaluations 9. Ability to understand study requirements and has sufficient fluency in one of the approved written translations of the Patient Information and Informed consent form 10. Signed informed consent	1. Currently pregnant 2. BMI \> 40 3. Marked hyperandrogenism (FAI \> 15) 4. Poor glycemic level control defined as glycohemoglobin (HbA1c) level \> 6.5% 5. Bleeding disorders, such as von Willebrand disease, thrombocytopenia, current use of anticoagulation medication, etc. 6. Active genital or urinary tract infection at the time of the procedure 7. Patient with known or suspected periovarian adhesions 8. Previous ovarian or tubal surgery such as ovarian drilling, endometriosis surgery, ovarian cysts surgery or sterilization procedure (i.e., tubal ligation) 9. Transvaginal ultrasound transducer cannot be brought into proximity of at least one ovary 10. Presence of a pathologic cyst (i.e. endometrioma, dermoid, etc.) of any size, or functional cyst \>15 mm on transvaginal ultrasound 11. Received \> 2 cycles of treatment with gonadotropins without a resulting pregnancy 12. Contraindicated to or known previous reaction to anesthesia or sedation regimen 13. Patient not willing to stop all concomitant first-line ovulation induction treatment (clomiphene citrate, letrozole, as well as metformin unless metformin is required for glycemic control) until the 3-month endpoint is reached 14. Male partner's total motile sperm count (TMSC) \< 10 million (unless participant is planning donor sperm IUI) 15. Patient is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study

Inclusion Criteria

Exclusion Criteria

1. Age ≥ 18 to ≤ 40 years
2. Infertility associated with oligo- or anovulation, AND EITHER:
2.1 Ultrasonographic evidence of PCOS (ovarian volume ≥ 10 mL and/or ovarian antral follicle count per ovary ≥ 20) OR
2.2 Evidence of hyperandrogenemia: either clinical (hirsutism defined as modified Ferriman-Gallwey (mFG) level ≥ 4-6 depending on ethnicity) or biochemical (raised serum concentration of androgens, testosterone ≥ 2.5 nmol/L, or FAI \> 4)
3. At least one ovary with ovarian volume ≥ 10.0 mL and neither ovary \> 23.0 mL
4. Ovarian accessibility: determined by ability to bring transvaginal ultrasound transducer into close proximity to at least one ovary. (Note: In the situation where only one ovary is appropriately sized according to the preceding criterion, then this requirement applies to the qualifying ovary.)
5. At least one patent fallopian tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years
6. Has not responded to first-line ovulation induction treatment or is contraindicated for, or declines, such treatment
7. Currently seeking immediate fertility
8. Willing to comply with Clinical Investigation Plan-specified follow-up evaluations
9. Ability to understand study requirements and has sufficient fluency in one of the approved written translations of the Patient Information and Informed consent form
10. Signed informed consent

1. Currently pregnant
2. BMI \> 40
3. Marked hyperandrogenism (FAI \> 15)
4. Poor glycemic level control defined as glycohemoglobin (HbA1c) level \> 6.5%
5. Bleeding disorders, such as von Willebrand disease, thrombocytopenia, current use of anticoagulation medication, etc.
6. Active genital or urinary tract infection at the time of the procedure
7. Patient with known or suspected periovarian adhesions
8. Previous ovarian or tubal surgery such as ovarian drilling, endometriosis surgery, ovarian cysts surgery or sterilization procedure (i.e., tubal ligation)
9. Transvaginal ultrasound transducer cannot be brought into proximity of at least one ovary
10. Presence of a pathologic cyst (i.e. endometrioma, dermoid, etc.) of any size, or functional cyst \>15 mm on transvaginal ultrasound
11. Received \> 2 cycles of treatment with gonadotropins without a resulting pregnancy
12. Contraindicated to or known previous reaction to anesthesia or sedation regimen
13. Patient not willing to stop all concomitant first-line ovulation induction treatment (clomiphene citrate, letrozole, as well as metformin unless metformin is required for glycemic control) until the 3-month endpoint is reached
14. Male partner's total motile sperm count (TMSC) \< 10 million (unless participant is planning donor sperm IUI)
15. Patient is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study

Contacts and Locations

Study Contact

Bertha Torres

CONTACT

7144571229

Bertha@Mayhealth.com

Christina Hawley, MPH

CONTACT

Christina@Mayhealth.com

Principal Investigator

Karl Hansen, MD, PhD

PRINCIPAL_INVESTIGATOR

Oklahoma University Health Sciences Center

Anuja Dokras, MD, PhD

PRINCIPAL_INVESTIGATOR

Penn Fertility Care

Study Locations (Sites)

UCSF Center for Reproductive Health

San Francisco, California, 94158

United States

The IVF Center

Winter Park, Florida, 32792

United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52245

United States

Cypress Medical Research Center

Wichita, Kansas, 67226

United States

University of Rochester, Strong Fertility Center

Rochester, New York, 14623

United States

UNC Fertility

Raleigh, North Carolina, 27617

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Penn Fertility Care

Philadelphia, Pennsylvania, 19104

United States

UW Health Generations Fertility Care

Middleton, Wisconsin, 53562

United States

Collaborators and Investigators

Sponsor: May Health

Karl Hansen, MD, PhD, PRINCIPAL_INVESTIGATOR, Oklahoma University Health Sciences Center
Anuja Dokras, MD, PhD, PRINCIPAL_INVESTIGATOR, Penn Fertility Care

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 Date2024-03-25

Study Completion Date2028-05

Study Record Updates

Study Start Date2024-03-25

Study Completion Date2028-05

Terms related to this study

Keywords Provided by Researchers

PCOS
Infertility related to PCOS
Ovulation restoration

Additional Relevant MeSH Terms

Polycystic Ovary Syndrome
Infertility, Female