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Prediction of Metaphase II Oocytes According to Different Levels of Serum AMH in Poor Responders Using the Antagonist Protocol

Plain-language guide to NCT03484611: not phased non-randomized trial of hCG (human chorionic gonadotropin) and Cetrorelix, 179 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03484611
Phase
not phased
Status
status unknown
Start
2013-01
Completion (planned or actual)
2018-04
Participants
179 (estimated)
Design
non-randomized, open label (everyone knows who gets what), diagnostic
Conditions studied
Invitro Fertilizaion
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test hCG (human chorionic gonadotropin) and Cetrorelix.

Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG injection.

It had three arms (groups): AMH < 0.3 ng/ml (active comparator), AMH 0.3 to 0.7 ng/ml (active comparator) and AMH > 0.7 to 1 ng/ml (active comparator).

Poor ovarian responders according to ESHRE consensus with serum AMH \< 0,3 ng/ml.

Poor ovarian responders according to ESHRE consensus with serum AMH 0.3 to 0.7 ng/ml.

Poor ovarian responders according to ESHRE consensus with serum AMH 0.7 to 1 ng/ml.

The registry classes the interventions as drug and procedure.

More on the Plan

A multicentric study looked into 179 poor responders who underwent antagonist protocol in ICSI cycles Induction of ovulation cycle: 1.

Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG injection. 5.

Ultrasound -guided fresh embryo transfer is performed on day 3 or 5 after fertilization. .

Embryo transfer was performed under abdominal ultrasound guide for proper embryo placement to the mid-uterine cavity. 0ne to three grade 1 or 2 embryos were transferred on day 3 after oocyte retrieval.

Who Took Part

Enrollment: 179 planned participants were the target.

It was open to women only aged from 20 years up to 45 years.

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

Examples of who could join: 3- On antagonist protocol 4- Poor responder according to ESHRE consensus; in which at least 2 of the following should be present:. Advanced maternal age (≥ 40 years old) or any other risk factor. A previous poor ovarian response (cycles cancelled or ≤ 3 oocytes with a conventional protocol). Presence and Adequate visualization of both ovaries. Uterine cavity within normal anatomy.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: severe male factor ; uterine factor (eg: fibroid, polyp, ashermann, .. etc); immunological disorder (eg: sle, aps, … etc).

How the Study Was Run

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

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

Being open-label, the hCG (human chorionic gonadotropin) study did not mask who received what.

It started in 2013-01 with completion listed for 2018-04.

It ran at 1 site in Egypt.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: Number of the retrieved oocytes (time frame: 34 hours after HCG injection).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of hCG (human chorionic gonadotropin) and Cetrorelix in 179 people.

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 Cetrorelix compound page, all human trials.

Our Notes on the Compounds

hCG (human chorionic gonadotropin): An LH analog that drives Leydig-cell testosterone production.

Cetrorelix: An FDA-approved GnRH antagonist used in IVF to prevent a premature LH surge.

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.