Progesterone Primed Ovarian Stimulation Protocol Versus Antagonist Protocol for PCO Patient

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05847660
• Other study ID #: D 319
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: April 2023
• Source: Fayoum University
• Contact: rehab A aboshama, Ass Professor
• Phone: 01156608221
• Email: ras07[@]fayoum.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: July 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• IVF
• Polycystic Ovary Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of oocytes retrieved per patient	The number of oocyte retieved by ovum pick up after controlled ovarien stimulation	12 months
Primary	The number of MII oocytes/per patient	the grade of maturity of oocyte under microscope	12 months
Primary	The fertilization rate/per patient.	The number of fertilized oocyte by sperm	12 months
Primary	Number of frozen embryos/per patient	the number of embryo frozen	12 month
Secondary	Incidence of early OHSS yes /no	size of th overies , presence of ascitis , pain and	12 months
Secondary	Pregnancy outcomes	Chemical pregnancy will be determined by serum ß hCG > 50 IU/L two weeks after ET.; In addition, clinical pregnancy will be confirmed by detecting fetal heartbeats 2 weeks following the positive ß hCG.	12 months