Progestin-primed Ovarian Stimulation Protocol Versus GnRH Antagonist Protocol in Polycystic Ovary Syndrome Patients Undergoing IVF/ICSI Cycles

What Was Tested

This registered not phased trial tested hCG (human chorionic gonadotropin) and HMG (Human Menopausal Gonadotropin) for pcos.

It had two arms (groups): PPOS group (active comparator) and GnRH antagonist (active comparator).

The registry classes the interventions as drug and procedure.

More on the Plan

Polycystic ovary syndrome (PCOS) is a common metabolic dysfunction and heterogeneous endocrine disorder.

It is usually characterized by a clustering of hyperandrogenism, hypersecretion of luteinizing hormone (LH) and hyperinsulinaemia, which could result in the arrest of ovarian follicular growth, oligo-ovulation or anovulation, menstrual dysfunction, hirsutism, infertility, pregnancy and/or neonatal complications.

Thus, GnRH antagonist regimens combined with a freeze-all strategy for women with PCOS are currently accepted as the most routine IVF procedures.

Choosing the appropriate progestin is crucial to the success of the Progestin-primed ovarian stimulation protocol (PPOS).

Who Took Part

The registry lists 200 planned participants were the target.

It was open to women only aged from 20 years up to 35 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Women who have a history of infertility ≥1year. Ages between 20 and 35 years. Patients diagnosed with PCOS according to the revised 2003 Rotterdam consensus and met 2 out of 3 criteria as follows (Rotterdam, 2004):. Oligo- and/or anovulation. Biochemical and/or clinical evidence of hyperandrogenism.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: endometriosis grade 3 or higher; patients who in the previous 3 months received hormonal treatments or other medications known to affect reproductive function, including oral contraceptives and gnrh agonists; documented history of ovarian surgery including laparoscopic ovarian drilling, ovarian endometrioma stripping and unilateral oophorectomy.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The pcos participants were allocated by chance, so the hCG (human chorionic gonadotropin) group and the comparison group should start out alike.

The hCG (human chorionic gonadotropin) group and the comparison group ran side by side rather than switching.

Neither the pcos participants nor the staff measuring them knew who was on hCG (human chorionic gonadotropin), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2021-11 with completion listed for 2023-11.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): clinical pregnancy rate (time frame: 6 weeks after embryo transfer).

It also tracked 5 secondary outcomes, for example the incidence of premature LH surges, fertilization rate, implantation rate, ongoing pregnancy rate and live birth rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of hCG (human chorionic gonadotropin) and HMG (Human Menopausal Gonadotropin) in 200 people with pcos.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page and the HMG (Human Menopausal Gonadotropin) compound page, PCOS research.