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Comparing the Efficacy of Urinary and Recombinant Human Chorionic Gonadotropin (hCG) on Oocyte Maturity

Plain-language guide to NCT01507376: phase 3 randomized trial of hCG (human chorionic gonadotropin), 180 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT01507376
Phase
phase 3
Status
completed
Start
2010-10
Completion (planned or actual)
2012-09
Participants
180 (actual)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
In Vitro Fertilization
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 3 trial, researchers set out to test hCG (human chorionic gonadotropin).

It had three arms (groups): one (experimental), one (experimental) and C: urinary hCG (experimental).

The registry classes the interventions as drug.

More on the Plan

When at least two follicles \> 18 mm diameter were seen, ovulation was triggered with hCG and patients allocated into three different study groups as per the following: 1.

Embryos transferred 2-3 days thereafter.

Data collection will be performed by using questionnaire to be filled as per the available records and laboratory results.

Who Took Part

The registry lists 180 actual participants took part.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Indication for IVF/ICSI and Long Protocol ovarian stimulation. Body mass index (BMI) ≤ 30 kg/m2. Regular menstrual cycles of 25-35 days. Tubal or male factor. Existence of both ovary and normal uterine cavity.

The full record lists 8 inclusion and 3 exclusion criteria; among the exclusions: poly cystic ovarian syndrome patients; contraindications of gonadotropins administration; poor response to ovulation induction in recent cycle.

How the Study Was Run

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

Because people in this hCG (human chorionic gonadotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2010-10 with completion listed for 2012-09.

It ran at 1 site in Iran.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of mature oocytes (time frame: Up to1 hour after oocyte retrieval).

It also tracked 6 secondary outcomes, for example number of retrieved oocytes per number of aspirated follicles proportion, fertilization rate, implantation rate, OHSS occurrence rate will be compared between three groups, chemical pregnancy rates and clinical pregnancy rates.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of hCG (human chorionic gonadotropin) in 180 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.

Our Notes on the Compound

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

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.