Ovarian PRP for Diminished Ovarian Reserve

NCT ID: NCT05790655

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-07
• Study Completion Date: 2025-12-31

Brief Summary

This prospective double-blinded randomized placebo control study aims to determine if In Vitro Fertilization (IVF) outcomes are improved by ovarian platelet-rich plasma injections (oPRP) for women diagnosed with diminished ovarian reserve (DOR). Women with DOR notoriously have the lowest chance of pregnancy and live birth compared to age-matched peers with a normal or robust ovarian reserve.

Detailed Description

A randomized, double-blind, placebo-controlled trial comparing ovarian injection of platelet-rich plasma vs. placebo in women diagnosed with diminished ovarian reserve at risk for a poor ovarian response (POR) between 35 to 42 years of age. Participants for this study include patients who are planning to undergo IVF with preimplantation genetic testing for aneuploidy (PGT-A) followed by a frozen embryo transfer (FET) cycle. Only patients with either a euploid embryo or eligible mosaic embryo (following consultation with a geneticist), as determined by PGT-A, will be allowed to proceed with a single blastocyst FET cycle

All patients will have a baseline ultrasound and blood work at the time of menses, approximately one month prior to starting their initial IVF cycle. Routine monitoring will be required to determine the day of ovulation. Once an LH surge is detected or if a lead follicle on pelvic ultrasound is deemed large enough to induce ovulation, a "trigger" shot with 250 mcg/0.5 mL of Ovidrel® will be self-administered subcutaneously (SQ). Based upon the patient's randomization, either oPRP or ovarian Serum (oS) injections will be performed under anesthesia and within 72 hours from the day of ovulation. Following their ovarian injections, all patients will return for monitoring with the onset of menses approximately 14 to 16 days from the date of ovulation.

A medication protocol will be determined at the start of each IVF cycle. Either a natural (nIVF), mild (mIVF) or conventional (cIVF) IVF protocol will be chosen by the treating physician. This determination will be based on findings from the repeat pelvic ultrasound with AFC and blood work for anti-mullerian hormone (AMH), follicle stimulating hormone (FSH), lutenizing hormone (LH), estradiol (E2), progesterone (P4), and beta-human chorionic gonadotrophin (B-hCG). Natural IVF will be considered for patients with only 1-2 antral follicles, mIVF for patients with 2-4 antral follicles observed, and cIVF for patients with four or more antral follicles visualized at the time stimulation started.

Patients will begin their designated protocol and return four to five days following medication start. A repeat pelvic ultrasound will be performed to measure the growth and size of all follicles visualized along with the endometrial thickness. Also, blood work for E2, FSH, LH, and P4 will be obtained. Monitoring for follicular and endometrial development will continue routinely and as needed, until the majority of all follicles observed have a mean diameter between 15 to 22 mm. Induction of ovulation will commence 35 and a half hours prior to oocyte retrieval, by self-administration of 10,000 IU hCG SQ.

The patient will receive deep IV sedation anesthesia by a board-certified anesthesiologist for her oocyte retrieval and placement of either her second oPRP or oS injections. Using transvaginal ultrasound guidance, all follicles visualized under ultrasound will be aspirated using standard practices by patients undergoing IVF at GNF. Aspirates will be collected in 10 ml test tubes. All oocytes will be assessed at the time of retrieval for maturity. All oocytes that are deemed mature (MII) will undergo intracytoplasmic sperm injection (ICSI), to maximize fertilization rates, 2-4 hours after identification of the first polar body. All immature (non MII) oocytes will be isolated under a stereomicroscope and transferred into maturation media and incubated further in a triple gas mixture (90% N2, 5% CO2, and 5% O2) for up to 24 hours to allow maturation prior to ICSI. Following the oocyte retrieval, either oPRP or oS will be performed as described previously.

Monitoring will recommence two weeks following the first oocyte retrieval to identify if any residual follicles or ovarian cysts are present. If the ovaries are deemed resting and no active ovarian cysts persist, then the patient will begin her second IVF cycle. Again, the medication protocol will be determined by findings observed on pelvic ultrasound including AFC and ovarian hormone testing. If the patient is deemed ineligible to start another IVF cycle, then she will return with the following menstrual period to begin her second IVF cycle. The process of monitoring patients, inducing ovulation and collecting oocytes will be identical to the first oocyte retrieval. However, no additional oPRP or oS injections will be performed.

Conditions

Diminished Ovarian Reserve

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

oPRP injections

Patients own prepared PRP will be injected into each ovary

Group Type: EXPERIMENTAL

oPRP

Intervention Type: OTHER

Prepared sample from patient's own blood collected and processed. Either PRP or serum is injected into the patient's ovary. All other care is standard for the IVF process

Placebo

Patient's serum will be injected into the ovary (not rich with platelets)

Group Type: PLACEBO_COMPARATOR

Placebo- Serum

Intervention Type: OTHER

Patient's serum is injected into ovary instead of PRP as placebo

Interventions

oPRP

Prepared sample from patient's own blood collected and processed. Either PRP or serum is injected into the patient's ovary. All other care is standard for the IVF process

Intervention Type: OTHER

Placebo- Serum

Patient's serum is injected into ovary instead of PRP as placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of diminished ovarian reserve
• Clinical diagnosis of poor ovarian response
• Women age 35-42

Exclusion Criteria

• Clinical diagnosis of premature ovarian failure
• Clinical diagnosis of menopause.
• Under 35 years of age
• Over 42 years of age

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Igenomix

INDUSTRY

Sponsor Role: collaborator

Generation Next Fertility

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jesse Hade, MD

Role: PRINCIPAL_INVESTIGATOR

Generation Next Fertility

Locations

Generation Next Fertility

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alicia Broussard, PhD

Role: CONTACT

a.broussard@generationnextfertility.com

3174456958

Jesse Hade, MD

Role: CONTACT

j.hade@generationnextfertility.com

2126410906

Facility Contacts

Jesse Hade, MD

Role: primary

j.hade@generationnextfertility.com

212-641-0906

Alicia Broussard, PhD

Role: backup

a.broussard@generationnextfertility.com

2126410906

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

IORG0010499_202301

Identifier Type: -

Identifier Source: org_study_id