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Early Preparation With Gonadotropin- Releasing Hormon (GnRh) Agonists Injection With Frozen-Thawed Embryo Transfer?

Plain-language guide to NCT03353883: phase 2, phase 3 randomized trial of Triptorelin, 200 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03353883
Phase
phase 2, phase 3
Status
status unknown
Start
2017-06-01
Completion (planned or actual)
2018-06
Participants
200 (estimated)
Design
randomized, quadruple-blind, treatment
Conditions studied
Infertility, Female
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 2, phase 3) is built around Triptorelin.

The study intended to include \>200 infertile women with impaired ovulation who will be subjected to HRT at D-21 of previous menstrual cycle (Group A) or D-1 of menses of replacement cycle (Group B).

All patients received the same luteal support in the form of intravaginal progesterone two day before embryos transfer until blood pregnancy test was performed 14 days later.

Clinical pregnancy was diagnosed by measurement of β-human chorionic gonadotropin level and was confirmed 2-weeks later by TVU.

It had two arms (groups): (Group A) Midluteal Triptorelin depot (active comparator) and (Group B)first day Triptorelin depot (active comparator).

The registry classes the interventions as drug.

More on the Plan

The classic Testart slow freezing and rapid thawing protocol was applied on stage-2 pronuclear embryos.

Endometrial thickness was measured in the midsagittal plane using transvaginal ultrasound (TVU).

Who Took Part

200 planned participants were the target.

It was open to women only aged from 20 years up to 40 years.

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

How the Study Was Run

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

The participants were allocated by chance, so the Triptorelin group and the comparison group should start out alike.

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

Blinding on both sides kept the participants and researchers unaware of who received Triptorelin.

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

It started in 2017-06-01 with completion listed for 2018-06.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: pregnancy outcome (time frame: 4 weeks).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Triptorelin in 200 people.

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

More context: the Triptorelin compound page, all human trials.

Our Notes on the Compound

Triptorelin: A 10-amino-acid GnRH analog (Trelstar, Decapeptyl, Triptodur) used in prostate cancer, early puberty and fertility protocols.

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.