Progesterone Primed Ovarian Stimulation Protocol Versus Antagonist Protocol for PCO Patient

Sponsor

Fayoum University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05847660

Collaborator

(none)

210

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

this study is designed to compare the Progesterone primed ovarian stimulation protocol versus the antagonist protocol as a method to stimulate PCO patients in ICSI cycles to decrease cost and decrease OHSS.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome Infertility IVF	Drug: Progesterone antagonist Drug: conventional antagonist protocol	N/A

Detailed Description

A Randomized controlled, non-blinded study (parallel-group study with 1:1 randomization) will be conducted at a Specialized Authorized IVF unit starting from January 2023 till completing the sample size. Randomization will be generated by a computer and held with one of the experimenters, and (n) of the black and red cards will be used for allocation concealment.

Participants: All PCO patients will be given informed consent about the study aims and written consent will be taken at the first visit to the infertility clinic of the Specialized Authorized IVF unit.

Patients will be categorized as (Group A) Progesterone primed ovarian stimulation protocol. (Group B) conventional antagonist protocol.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

this is a randomized controlled non-blinded study. it will include 210 pt all of them PCO pt with infertilitythis is a randomized controlled non-blinded study. it will include 210 pt all of them PCO pt with infertility

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized Controlled Study of Progesterone Primed Ovarian Stimulation Protocol Versus Antagonist Protocol for PCO Patients in Intracytoplasmic Sperm Injection Cycles

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Progesterone primed ovarian stimulation protocol. Group (A): Women in progesterone primed (PPOS) will be prescribed a 30 mg oral dose of dydrogesterone (Duphaston, Abbott, Egypt) from the 2nd day of the cycle and continued until the triggering day. Vaginal sonography will be done for all patients since 6th day of the cycle.	Drug: Progesterone antagonist Group (A): Women in progesterone primed (PPOS) will prescribed 30 mg oral dose of dydrogesterone (duphaston, Abbott, Egypt) from the 2nd day of the cycle and continued until triggering day. Vaginal sonography will be done for all patients since the 6th day of the cycle. Other Names: duphaston
Active Comparator: conventional antagonist protocol. Group (B): Women in the antagonist group will be monitored by transvaginal ultrasonography till the size of dominant follicles reached to 12-13 mm, 0.25 mg of Cetrotide (Merck-Serono, Germany) will be injected subcutaneously daily and continued until triggering day, follow up for all patients in both groups by transvaginal ultrasound every other day.	Drug: conventional antagonist protocol Group (B): Women in the antagonist group will be monitored by transvaginal ultrasonography till the size of dominant follicles reached to 12-13 mm, 0.25 mg of cetrotide (Merck-Serono ,Germany) will be injected subcutaneously daily and continued until triggering day, follow up for all patients in both groups by transvaginal ultrasound every other day. Other Names: 0.25 mg of cetrotide

Arm

Intervention/Treatment

Active Comparator: Progesterone primed ovarian stimulation protocol.

Group (A): Women in progesterone primed (PPOS) will be prescribed a 30 mg oral dose of dydrogesterone (Duphaston, Abbott, Egypt) from the 2nd day of the cycle and continued until the triggering day. Vaginal sonography will be done for all patients since 6th day of the cycle.

Drug: Progesterone antagonist

Group (A): Women in progesterone primed (PPOS) will prescribed 30 mg oral dose of dydrogesterone (duphaston, Abbott, Egypt) from the 2nd day of the cycle and continued until triggering day. Vaginal sonography will be done for all patients since the 6th day of the cycle.

Other Names:

duphaston

Active Comparator: conventional antagonist protocol.

Group (B): Women in the antagonist group will be monitored by transvaginal ultrasonography till the size of dominant follicles reached to 12-13 mm, 0.25 mg of Cetrotide (Merck-Serono, Germany) will be injected subcutaneously daily and continued until triggering day, follow up for all patients in both groups by transvaginal ultrasound every other day.

Drug: conventional antagonist protocol

Group (B): Women in the antagonist group will be monitored by transvaginal ultrasonography till the size of dominant follicles reached to 12-13 mm, 0.25 mg of cetrotide (Merck-Serono ,Germany) will be injected subcutaneously daily and continued until triggering day, follow up for all patients in both groups by transvaginal ultrasound every other day.

Other Names:

0.25 mg of cetrotide

Outcome Measures

Primary Outcome Measures

The number of oocytes retrieved per patient [12 months]
The number of oocyte retieved by ovum pick up after controlled ovarien stimulation
The number of MII oocytes/per patient [12 months]
the grade of maturity of oocyte under microscope
The fertilization rate/per patient. [12 months]
The number of fertilized oocyte by sperm
Number of frozen embryos/per patient [12 month]
the number of embryo frozen

Secondary Outcome Measures

Incidence of early OHSS yes /no [12 months]
size of th overies , presence of ascitis , pain and
Pregnancy outcomes [12 months]
Chemical pregnancy will be determined by serum β hCG > 50 IU/L two weeks after ET. In addition, clinical pregnancy will be confirmed by detecting fetal heartbeats 2 weeks following the positive β hCG.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

1. PCO patients based on Rotterdam criteria (2003), including polycystic ovaries, oligo-anovulation, as well as the biochemical or clinical signs of hyperandrogenism (Rotterdam et al, 2003).