Predictors of Ovarian Reserve in Infertile Women

Plain-language guide to NCT02896023: phase 4 non-randomized trial of HMG (Human Menopausal Gonadotropin), 100 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02896023
Phase: phase 4
Status: status unknown
Start: 2016-09
Completion (planned or actual): 2020-01
Participants: 100 (estimated)
Design: non-randomized, triple-blind, diagnostic
Conditions studied: Ovarian Reserve
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 4 trial, researchers set out to test HMG (Human Menopausal Gonadotropin).

Patients will be subjected to: A.

Clinical evaluation including history and examination B.

It had two arms (groups): pregnant (active comparator) and Not pregnant (active comparator).

Women with positive pregnancy test after induction of ovulation and ICSI.

Women with negative pregnancy test after induction of ovulation and ICSI.

The registry classes the interventions as drug.

Who Took Part

100 planned participants were the target.

It was open to women only aged from 20 years up to 39 years.

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

Examples of who could join: Less than 39 years old,. Normal menstrual cycle with a range of 24 to 35 days. Normal seum prolactin. Normal uterine cavity determined by previous hysterosalpingography or hysteroscopy.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: women with endometriosis;; abnormal endocrine functions such as diabetes mellitus, thyroid disorders, and adrenal abnormalities; general diseases, those with ovarian cysts, or those who have azospermia partners.

How the Study Was Run

Design: non-randomized, parallel-group and triple-blind.

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

Neither the participants nor the staff measuring them knew who was on HMG (Human Menopausal Gonadotropin), so expectations could not easily colour the readings.

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

It started in 2016-09 with completion listed for 2020-01.

It ran at 1 site in Egypt.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: positive pregnancy test (time frame: 14 days after embryo transfer).

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of HMG (Human Menopausal Gonadotropin) in 100 people.

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.

Our Notes on the Compound

HMG (Human Menopausal Gonadotropin): Menotropins: a glycoprotein preparation that supplies follicle-stimulating hormone (FSH) and luteinizing hormone (LH) activity.

HMG (Human Menopausal Gonadotropin) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.