Intra-Ovarian PRP Compared With Gonadotropin for Ovarian Response in Letrozole-Resistant PCOS

NCT07777640 | Completed

• 1 other identifier: BMU-5512-PRP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized clinical trial is to compare autologous platelet-rich plasma (PRP) with gonadotropin for improving ovarian response in women with letrozole-resistant polycystic ovary syndrome (PCOS). Researchers will compare the two treatments to assess ovarian response, ovulation rates, and pregnancy rates. Participants will be randomly assigned to receive either intra-ovarian autologous PRP or gonadotropin treatment and will be followed for three consecutive cycles.

Conditions

Polycystic Ovary Syndrome (PCOS)

Keywords

Letrozole-resistant PCOS; Autologous platelet-rich plasma; Gonadotropin; Ovarian response; Ovulation

Outcome Measures

Primary Outcomes (4)

• Proportion of Participants With Developing Follicles ≥14 mm

  Developing follicles will be assessed by transvaginal ultrasonography. A follicle measuring ≥14 mm in diameter will be considered a developing follicle.

  Day 12 to Day 14 of each treatment cycle, where each treatment cycle is defined as one menstrual cycle from the first day of menstrual bleeding to the first day of the next menstrual bleeding, for up to three consecutive treatment cycles.

• Proportion of Participants With Mature Follicles

  Mature follicle will be defined as a follicle measuring 18 to 25 mm in diameter on transvaginal ultrasonography.

  Day 12 to Day 14 of each treatment cycle, where each treatment cycle is defined as one menstrual cycle from the first day of menstrual bleeding to the first day of the next menstrual bleeding, for up to three consecutive treatment cycles.

• Proportion of Participants With Endometrial Thickness ≥7 mm

  Endometrial thickness will be measured by transvaginal ultrasonography. An endometrial thickness of ≥7 mm will be considered the target response

  Day 12 to Day 14 of each treatment cycle, where each treatment cycle is defined as one menstrual cycle from the first day of menstrual bleeding to the first day of the next menstrual bleeding, for up to three consecutive treatment cycles.

• Proportion of Participants With Ovulation

  Ovulation will be assessed by mid-luteal serum progesterone measurement. A serum progesterone level \>3 ng/mL will be considered indicative of ovulation

  7 days after ovulation trigger in each treatment cycle, where each treatment cycle is defined as one menstrual cycle from the first day of menstrual bleeding to the first day of the next menstrual bleeding, for up to three consecutive treatment cycles.

Secondary Outcomes (1)

• Pregnancy Rate

  One week after a missed menstrual period in each treatment cycle, where each treatment cycle is defined as one menstrual cycle from the first day of menstrual bleeding to the first day of the next menstrual bleeding, for up to three consecutive treatment

Study Arms (2)

Intra-Ovarian Autologous PRP

EXPERIMENTAL

Participants will receive intra-ovarian autologous platelet-rich plasma (PRP) by laparoscopy and will be followed for ovarian response, ovulation, and pregnancy outcomes for three consecutive cycles

Biological: Autologous Platelet-Rich Plasma (PRP)

Gonadotropin

ACTIVE COMPARATOR

Participants will receive gonadotropin treatment for three consecutive cycles and will be followed for ovarian response, ovulation, and pregnancy outcomes.

Drug: Gonadotropin

Interventions

Autologous Platelet-Rich Plasma (PRP) BIOLOGICAL

Participants will receive 5 mL of autologous platelet-rich plasma (PRP) in each ovary by laparoscopy during the proliferative phase of the menstrual cycle. Following the procedure, participants will be monitored for spontaneous ovulation for three consecutive cycles.

Intra-Ovarian Autologous PRP

Gonadotropin DRUG

Participants will receive recombinant follicle-stimulating hormone (rFSH) 75 IU intramuscularly on days 5 and 7 of the menstrual cycle, followed by human menopausal gonadotropin (hMG) 75 IU intramuscularly on days 9 and 11. Follicular development will be monitored by transvaginal ultrasonography. When at least one mature follicle measuring 18-25 mm is identified, ovulation will be triggered with human chorionic gonadotropin (hCG) 5,000 IU intramuscularly, followed by timed intercourse.

Gonadotropin

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18-35 years diagnosed with polycystic ovary syndrome (PCOS) based on the Rotterdam criteria.
• Primary or secondary subfertility.
• Patients with a history of letrozole resistance (failure to ovulate with standard dose of letrozole).

You may not qualify if:

• Body Mass Index (BMI) \<18.5 kg/m² or ≥30 kg/m².
• Presence of other causes of infertility (e.g., endometriosis, tubal factor, severe male factor infertility).
• Patients with uncontrolled endocrine disorders (e.g., thyroid dysfunction, hyperprolactinemia).
• Any contraindication to platelet-rich plasma (PRP) therapy (coagulation disorder or current use of anticoagulant).
• Patient not fit for surgery.
• Hypersensitivity to gonadotropin.

Sponsors & Collaborators

• Bangladesh Medical University: lead

Study Sites (1)

Department of Reproductive Endocrinology and Infertility, Bangladesh Medical University

Dhaka, Dhaka Division, 1000, Bangladesh

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Gonadotropins

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MS Phase-B Resident, Reproductive Endocrinology and Infertility

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 20, 2026
• Study Start: June 1, 2025
• Primary Completion: May 20, 2026
• Study Completion: May 28, 2026
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)