DPOS Versus GnRH Antagonist Protocol for Oocyte Accumulation in Low Ovarian Reserve Patients: An RCT

NCT05847283 | Recruiting DMC

• 1 other identifier: DYDR-C22-0313
• Study Type: interventional
• Target: 730
• Locations: 1 country
• Sites: 2

Brief Summary

One of the barriers in patients with diminished ovarian reserve (DOR) is the significantly reduced number of oocytes resulting in fewer oocytes collected and embryos formed. Many ovarian stimulation strategies have been proposed to improve oocyte or embryo quantity which is oocyte accumulation could be a potential option with a comparable success rate and reasonable cost. Progestin-primed ovarian stimulation (PPOS) protocol could be suggested as an alternative method of premature Luteinizing hormone (LH) prevention in IVF. It favors segment Assisted Reproductive Technology (ART) cycles such as frozen embryo transfer (FET), oocyte donor, fertility preservation, and oocyte accumulation set. The protocol is more patient-friendly and affordable than the GnRH antagonist regimen regarding LH suppression during ovarian stimulation. Many PPOS protocols have been proposed in which the three most common agents include Dydrogesterone (DYG), Micronised Progesterone (MIP), and Medroxyprogesterone acetate (MPA). Indeed, DYG seems to have some advantages, including oral administration and safety which has been used in the treatment of threatened abortion. Initial evidence of PPOS protocol suggests that oocyte quantity and quality are comparable with other ovarian stimulation regimens. However, data related to the PPOS protocol has not been well documented, including Dydrogesteron-primed ovarian stimulation (DPOS). There has not been an RCT with a large sample size and well-designed to provide more substantial evidence. A randomized trial to compare the effectiveness of PPOS and GnRH antagonist protocol in IVF is urgently needed.

Conditions

Diminished Ovarian Reserve

Keywords

Progestin priming ovarian stimulation; Oocyte accumulation; Diminished ovarian reserve; GnRH antagonist; Oocyte vitrification; Dydrogesterone

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate after the first embryo transfer

  Ongoing pregnancy is defined as pregnancy with a detectable heart rate at 11 - 12 weeks of gestation after the completion of the first transfer.

  11 - 12 weeks of gestation

Secondary Outcomes (23)

• Serum LH level

  On day 1, day 5, day 8 of FSH administration, on the trigger day and 12 hours after the trigger injection

• Serum Estradiol level

  On day 1, day 5, day 8 of FSH administration, on the trigger day and 12 hours after the trigger injection

• Serum Progesterone level

  On day 1, day 5, day 8 of FSH administration, on the trigger day and 12 hours after the trigger injection

• Premature LH surge

  on the day of trigger, an average of 2 weeks after FSH administration

• Duration of ovarian stimulation

  From the day 1 of FSH administration to the day of trigger, an average of 2 weeks after FSH administration

Study Arms (2)

DPOS protocol

ACTIVE COMPARATOR

Women will receive oral Dydrogesterone 10mg (Duphaston 10mg) t.i.d daily from the first day of ovarian stimulation till the day of final oocyte maturation.

Procedure: Dydrogesterone priming ovarian stiumulation protocol

GnRH antagonist protocol

PLACEBO COMPARATOR

Women will receive GnRH antagonist (Ganirelix 0.25mg) once subcutaneously daily from day 5 of ovarian stimulation till the day of final oocyte maturation

Procedure: GnRH antagonist protocol

Interventions

GnRH antagonist protocol PROCEDURE

In the fixed GnRH antagonist protocol, hMG 225 IU will be administered daily from menstrual cycle day 2 - 4 (CD2 - CD4) and s.c. administration of GnRH antagonist (Ganirelix 0.25 mg) will be initiated daily on the 5th day of stimulation. Treatment with hMG and GnRH antagonist will be continued until the day of final oocyte maturation triggering.

Also known as: GnRHanta protocol

GnRH antagonist protocol

Dydrogesterone priming ovarian stiumulation protocol PROCEDURE

Patients will be co-administered with oral DYG (Duphaston) 30mg/d and Human Menopausal Gonadotrophin (hMG) 225 IU/day (IU/d) via intramuscular injection from menstrual cycle day 2 - 4 (CD2 - CD4) to the day of final oocyte maturation.

Also known as: DPOS protocol

DPOS protocol

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Woman aged between 18 and 37 years
• AFC ≤ 5 and/or AMH ≤ 1.2 ng/ml
• Agree to perform freeze-all strategy and single frozen blastocyst embryo transfer

You may not qualify if:

• Oocyte recipient
• Indication of preimplantation genetic testing
• Known allergic reactions to medications in the Study (progesterone products, GnRH antagonist….)
• Basal FSH above 15mIU/mL.
• Have contraindications of ART treatment (e.g. critical or acute diseases)
• Retrieved sperm
• Repeated Implantation failure ( ≥ 3 failed embryo transfers with good-quality embryos)
• Inability to comply with the study procedures.
• Patients with a history of thyroid cancer who are on hormone replacement therapy or those diagnosed with thyroid diseases at the time of eligibility assessment

Sponsors & Collaborators

• Abbott: collaborator
• Tam Anh TP. Ho Chi Minh General Hospital: lead

Study Sites (2)

IVFTA

Hanoi, Hanoi, 100000, Vietnam

RECRUITING

Ivfta Hcmc

Ho Chi Minh City, Ho Chi Minh, 70000, Vietnam

RECRUITING

Study Officials

• Nhu H Giang, MD., MCE

  Tam Anh TP. Ho Chi Minh General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nhu H Giang, MD., MCE

CONTACT

+84 793 231 721; nhugh@tahospital.vn

Loc M T Nguyen, MSc

CONTACT

+84 39 2045478; locnmt@tahospital.vn

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: MD., MCE.

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: May 6, 2023
• Study Start: June 22, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)