FSH Followed by HMG vs FSH Plus HMG in IVF

What Was Tested

The trial (phase 4) is built around HMG (Human Menopausal Gonadotropin).

The aim of this study is to compare the clinical outcomes of sequential administration of FSH and HP-hMG FSH alone versus concomitant administration of FSH and HP-hMG during controlled ovarian stimulation in IVF cycles.

It had two arms (groups): FSH then HP-hMG (active comparator) and FSH + HP-hMG (active comparator).

The registry classes the interventions as drug.

More on the Plan

Women who are planned to be subjected to IVF/ICSI through COS by long GnRHa protocol will be assessed for possibility of participation in their study.

Eligible participants in their study will be those with regular menstrual cycle (21-35 days) and normal uterine anatomy (confirmed by transvaginal ultrasound examination and in some cases hysteronsalpingography and hysteroscopy).

A written informed consent will be taken from each women selected to participate before inclusion in the study.

All women participating in the study will start GnRHa on day 21 of the preceding cycle and when down regulation occurs each woman will be randomly allocated into one of the two groups; group 1 and group 2.

Who Took Part

530 planned participants were the target.

It was open to women only aged from 20 years up to 37 years.

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

Examples of who could join: Women who are planned to be subjected to IVF/ICSI through COS by long GnRHa protocol. Women with regular menstrual cycle (21-35 days) and normal uterine anatomy (confirmed by transvaginal ultrasound examination and in some cases hysteronsalpingography and hysteroscopy).

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: age \< 20 or \> 37 years; body mass index (bmi) \< 18 or \> 30 kg/m2; low ovarian reserve (afc \< 7 and/or amh \< 1.1 ng/ml).

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got HMG (Human Menopausal Gonadotropin) and who got the comparison, which limits bias.

The HMG (Human Menopausal Gonadotropin) group and the comparison group ran side by side rather than switching.

In this single-blind HMG (Human Menopausal Gonadotropin) study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2020-06-30 with completion listed for 2022-05-30.

It ran at 3 sites in Egypt (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Ongoing pregnancy rate (time frame: 12 weeks gestational age).

It also tracked 3 secondary outcomes, for example Clinical pregnancy rate, Implantation rate and Miscarriage rate.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of HMG (Human Menopausal Gonadotropin) in 530 people.

With 530 participants it is a large trial for this field.

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

More context: the HMG (Human Menopausal Gonadotropin) compound page, all human trials.