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Comparison of Treatment Modalities in Poor Responders Undergoing IVF

Plain-language guide to NCT02158689: not phased randomized trial of HMG (Human Menopausal Gonadotropin), 80 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT02158689
Phase
not phased
Status
completed
Start
2014-06
Completion (planned or actual)
2015-08
Participants
80 (estimated)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Poor Responders
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test HMG (Human Menopausal Gonadotropin).

The accurate identification and efficient management of poor responders remains one of the most enigmatic challenges in assisted reproductive technology (ART).

The investigators study will compare the letrozole/antagonist protocol to the hMG/antagonist protocol in women who poor responders.

It had two arms (groups): human menopausal gonadotropin (hMG) (active comparator) and Letrozole (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 80 planned participants were the target.

It was open to women only aged from 18 years up to 42 years.

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

Examples of who could join: Patients will be considered eligible if they are poor ovarian responders according to the Bologna criteria (Ferraretti et al., 2011). Two out of three of the following criteria are essential in order to classify a patient as poor ovarian responder:. Advanced maternal age (≥40 years) or any other risk factor for poor ovarian response;. A poor ovarian response (≤3 oocytes with a conventional stimulation protocol); or. An abnormal ovarian reserve test (antral follicle count, \<7 follicles or anti-Mullerian hormone, \<1.1 ng/ml).

The full record lists 5 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the HMG (Human Menopausal Gonadotropin) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the HMG (Human Menopausal Gonadotropin) study did not mask who received what.

It started in 2014-06 with completion listed for 2015-08.

It ran at 1 site in Turkey (Türkiye).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Ongoing pregnancy rate (time frame: up to 2 weeks).

It also tracked 5 secondary outcomes, for example Cancellation Rate, Number of oocytes retrieved, Number of transferable embryos, Implantation rate and Clinical pregnancy rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of HMG (Human Menopausal Gonadotropin) in 80 people.

The trial is marked completed; 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.

Related Pages

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.