Polycystic Ovary Syndrome (PCOS)NCT07777640
Intra-Ovarian PRP Compared With Gonadotropin for Ovarian Response in Letrozole-Resistant PCOS
A study testing Autologous Platelet-Rich Plasma (PRP) and Gonadotropin in people with Polycystic Ovary Syndrome (PCOS), run by Bangladesh Medical University at 1 site in Bangladesh.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS)
- What is being tested?
- Autologous Platelet-Rich Plasma (PRP) and Gonadotropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jun 2025to 28 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
Department of Reproductive Endocrinology and Infertility, Bangladesh Medical University
Dhaka, Dhaka Division, 1000
About this study
Official title: Effect of Intra-Ovarian Injection of Autologous Platelet Rich Plasma Compared to Gonadotropin on Ovarian Response in Letrozole Resistant Polycystic Ovary Syndrome
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.
Read the detailed description
Polycystic ovary syndrome (PCOS) is a common reproductive endocrine disorder that may cause anovulation and infertility. Letrozole is a first-line ovulation induction agent; however, a proportion of women with PCOS are resistant to standard-dose letrozole and may require second-line treatment such as gonadotropin therapy. Gonadotropin treatment can be effective but requires monitoring because of the risks of ovarian hyperstimulation and multiple pregnancy. This randomized clinical trial is designed to evaluate and compare the effects of intra-ovarian autologous platelet-rich plasma (PRP) and gonadotropin treatment on ovarian response in women with letrozole-resistant PCOS.
Eligible women attending the Department of Reproductive Endocrinology and Infertility, Bangladesh Medical University, will be identified according to the Rotterdam diagnostic criteria for PCOS and screened according to the study inclusion and exclusion criteria. Participants will receive detailed information about the study and provide written informed consent before enrollment. Sociodemographic information, relevant clinical history, and investigations will be recorded using a structured data collection sheet.
Participants will be randomly allocated into two intervention groups using a computer-generated random number sequence. Participants in the experimental group will receive 5 mL of autologous platelet-rich plasma 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 months.
Participants in the gonadotropin group will receive gonadotropin stimulation for three consecutive cycles. Follicular development will be monitored by transvaginal ultrasonography. Gonadotropin stimulation will be administered according to the study protocol, followed by human chorionic gonadotropin triggering when a mature follicle is identified. Timed intercourse will be advised following triggering. Ovulation will subsequently be assessed by mid-luteal serum progesterone measurement.
Tubal patency will be assessed as part of the infertility evaluation to exclude tubal factor infertility. In participants allocated to the PRP group, tubal evaluation will be performed during the laparoscopic procedure undertaken for intra-ovarian PRP administration. In participants allocated to the gonadotropin group, tubal evaluation will be performed before initiation of gonadotropin stimulation. Participants found to have bilateral tubal block will be excluded from the study.
The primary outcome is ovarian response, assessed by transvaginal ultrasonography, including the proportion of participants developing follicles measuring at least 14 mm, the proportion developing mature follicles measuring 18-25 mm, and endometrial thickness of at least 7 mm. Ovulation rate will be assessed by mid-luteal serum progesterone, with a progesterone concentration greater than 3 ng/mL considered indicative of ovulation. Pregnancy rate will be assessed by serum beta-human chorionic gonadotropin.
Participants will also be monitored for treatment-related adverse effects, including ovarian hyperstimulation syndrome, multiple pregnancy, and injection-site reactions. The study will compare ovarian response, ovulation rate, and pregnancy rate between the intra-ovarian autologous PRP group and the gonadotropin group over three consecutive treatment cycles/months.
The study aims to determine whether intra-ovarian autologous PRP may improve ovarian response and ovulation in women with letrozole-resistant PCOS compared with gonadotropin treatment.
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Being tested
- Autologous Platelet-Rich Plasma (PRP), Gonadotropin
- Keywords
- Letrozole-resistant PCOS, Autologous platelet-rich plasma, Gonadotropin, Ovarian response, Ovulation
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
GonadotropinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Gonadotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Pregnancy will be assessed by quantitative serum beta-human chorionic gonadotropin (β-hCG) measurement one week after a missed menstrual period. Clinical pregnancy will be confirmed by transvaginal ultrasonography at 6-8 weeks of gestation
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Jun 2025
- Primary completion20 May 2026
- Study completion28 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayma Uddin, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777640
- Sponsor's protocol ID
- BMU-5512-PRP
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intra-Ovarian Injection of Autologous Platelet Rich Plasma Compared to Gonadotropin on Ovarian Response in Letrozole Resistant Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT07777640
- Acronym / sponsor ID
- BMU-5512-PRP
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Keywords
- Letrozole-resistant PCOS, Autologous platelet-rich plasma, Gonadotropin, Ovarian response, Ovulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 28 May 2026 (actual)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Polycystic ovary syndrome (PCOS) is a common reproductive endocrine disorder that may cause anovulation and infertility. Letrozole is a first-line ovulation induction agent; however, a proportion of women with PCOS are resistant to standard-dose letrozole and may require second-line treatment such as gonadotropin therapy. Gonadotropin treatment can be effective but requires monitoring because of the risks of ovarian hyperstimulation and multiple pregnancy. This randomized clinical trial is designed to evaluate and compare the effects of intra-ovarian autologous platelet-rich plasma (PRP) and gonadotropin treatment on ovarian response in women with letrozole-resistant PCOS.
Eligible women attending the Department of Reproductive Endocrinology and Infertility, Bangladesh Medical University, will be identified according to the Rotterdam diagnostic criteria for PCOS and screened according to the study inclusion and exclusion criteria. Participants will receive detailed information about the study and provide written informed consent before enrollment. Sociodemographic information, relevant clinical history, and investigations will be recorded using a structured data collection sheet.
Participants will be randomly allocated into two intervention groups using a computer-generated random number sequence. Participants in the experimental group will receive 5 mL of autologous platelet-rich plasma 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 months.
Participants in the gonadotropin group will receive gonadotropin stimulation for three consecutive cycles. Follicular development will be monitored by transvaginal ultrasonography. Gonadotropin stimulation will be administered according to the study protocol, followed by human chorionic gonadotropin triggering when a mature follicle is identified. Timed intercourse will be advised following triggering. Ovulation will subsequently be assessed by mid-luteal serum progesterone measurement.
Tubal patency will be assessed as part of the infertility evaluation to exclude tubal factor infertility. In participants allocated to the PRP group, tubal evaluation will be performed during the laparoscopic procedure undertaken for intra-ovarian PRP administration. In participants allocated to the gonadotropin group, tubal evaluation will be performed before initiation of gonadotropin stimulation. Participants found to have bilateral tubal block will be excluded from the study.
The primary outcome is ovarian response, assessed by transvaginal ultrasonography, including the proportion of participants developing follicles measuring at least 14 mm, the proportion developing mature follicles measuring 18-25 mm, and endometrial thickness of at least 7 mm. Ovulation rate will be assessed by mid-luteal serum progesterone, with a progesterone concentration greater than 3 ng/mL considered indicative of ovulation. Pregnancy rate will be assessed by serum beta-human chorionic gonadotropin.
Participants will also be monitored for treatment-related adverse effects, including ovarian hyperstimulation syndrome, multiple pregnancy, and injection-site reactions. The study will compare ovarian response, ovulation rate, and pregnancy rate between the intra-ovarian autologous PRP group and the gonadotropin group over three consecutive treatment cycles/months.
The study aims to determine whether intra-ovarian autologous PRP may improve ovarian response and ovulation in women with letrozole-resistant PCOS compared with gonadotropin treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-Ovarian Autologous PRP | Experimental | Biological: Autologous Platelet-Rich Plasma (PRP)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 |
| Gonadotropin | Active comparator | Drug: GonadotropinParticipants will receive gonadotropin treatment for three consecutive cycles and will be followed for ovarian response, ovulation, and pregnancy outcomes. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Platelet-Rich Plasma (PRP)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. | Biological | Intra-Ovarian Autologous PRP |
| GonadotropinParticipants 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. | Drug | Gonadotropin |
Primary outcome
Proportion of Participants With Developing Follicles ≥14 mm
Time frame: 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.
Developing follicles will be assessed by transvaginal ultrasonography. A follicle measuring ≥14 mm in diameter will be considered a developing follicle.
Proportion of Participants With Mature Follicles
Time frame: 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.
Mature follicle will be defined as a follicle measuring 18 to 25 mm in diameter on transvaginal ultrasonography.
Proportion of Participants With Endometrial Thickness ≥7 mm
Time frame: 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.
Endometrial thickness will be measured by transvaginal ultrasonography. An endometrial thickness of ≥7 mm will be considered the target response
Proportion of Participants With Ovulation
Time frame: 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.
Ovulation will be assessed by mid-luteal serum progesterone measurement. A serum progesterone level >3 ng/mL will be considered indicative of ovulation
1 secondary outcome
Pregnancy Rate
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Polycystic Ovary Syndrome (PCOS)
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Platelet-Rich Plasma (PRP) and Gonadotropin in people with Polycystic Ovary Syndrome (PCOS), run by Bangladesh Medical University at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Developing Follicles ≥14 mm (time frame: 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.