Progesterone Primed Ovarian Stimulation Protocol Versus Antagonist Protocol for PCO Patient

NCT ID: NCT05847660

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-07-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Polycystic Ovary Syndrome Infertility IVF

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Progesterone antagonist

Intervention Type DRUG

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.

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.

Group Type ACTIVE_COMPARATOR

conventional antagonist protocol

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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duphaston 0.25 mg of cetrotide

Eligibility Criteria

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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).

2\. Age less than 40 years old. 3. Primary infertility for 2 years and secondary infertility for 1 year.

Exclusion Criteria

\- Non-PCO patients as:

* Congenital adrenal hyperplasia
* Hyperprolactinemia.
* Recurrent implantation failure.
* Hydrosalpinx.
* Uterine pathology.
* Uncontrolled medical disorder eg DM, HTN
* Male factor infertility.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fayoum University

OTHER

Sponsor Role lead

Responsible Party

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rehab abdelhamid aboshama

associate professor of obstetrics and gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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rehab A aboshama, Ass Professor

Role: CONTACT

01156608221 ext. +2

Other Identifiers

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D 319

Identifier Type: -

Identifier Source: org_study_id

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