Progesterone-Primed Ovarian Simulation in Controlled-ovarian Simulation of Infertile PCOS Patients

Progesterone-Primed Ovarian Stimulation Might be a Safe and Effective Alternative to GnRH-antagonist Protocol for Controlled-Ovarian Stimulation of Infertile PCOS Women

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05939284

Enrollment

238

Registered

2023-07-11

Start date

2021-06-01

Completion date

2023-01-25

Last updated

2023-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PCOS

Brief summary

The study evaluated the safety and efficacy of the progesterone-primed ovarian stimulation (PPOS) coupled with gonadotropin (FSH) for infertile women with polycystic ovary syndrome (PCOS) who were assigned for ICSI and frozen blastocyst transfer. 200 infertile women were divided randomly into Group C, which received Cetrorelix injection (0.25 mg daily) on day-6, and Group S, which received oral dydrogesterone (20 mg/day) on day-2 of the menstrual cycle till the trigger day. All patients received an FSH injection of 225 IU daily from day-2 till triggering day. ICSI was performed and day-5 blastocysts underwent vitrification ultra-rapid cryopreservation till being transferred. Outcomes included the ability of PPOS to suppress the premature luteinizing hormone (LH) surge and prevent the development of ovarian hyperstimulation syndrome (OHSS), the incidence of profound LH suppression, the number of retrieved M2 oocyte and fertilization, chemical and clinical pregnancy rates, and the miscarriage rate.

Interventions

DRUGInjection of Cetrorelix

Patients received Cetrorelix subcutaneous injection on the day-6 in a dose of 0.25 daily till the trigger day.

DRUGOral insertion of dydrogeserone

Patients received dydrogesterone in an oral dose of 20 mg/day in parallel with gonadotropin injection from day-2 of the menstrual cycle till the trigger day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 35 Years

Healthy volunteers

Inclusion criteria

* Infertile PCOS women; * aged 20-35 years; * had BMI \<35 kg/m2.

Exclusion criteria

* Women who were younger than 20 or older than 35 years, * obese of grade II or III, * had poor OR, other causes of infertility, * had previous attempts of IVF, had a history of repeated pregnancy loss.

Design outcomes

Primary

Measure	Time frame	Description
Success rate of PPOS in relation to Premature LH surge suppression	12 months	the success rate of PPOS as regards the suppression of premature LH surge and prevention of the development of OHSS.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026