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Final Oocyte Maturation Via Administration of GnRH Agonists Followed By Luteal Support With hCG

Plain-language guide to NCT01638026: phase 4 interventional trial of Triptorelin, 93 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT01638026
Phase
phase 4
Status
completed
Start
2012-09
Completion (planned or actual)
2017-07
Participants
93 (actual)
Design
na, open label (everyone knows who gets what), treatment
Conditions studied
Infertility
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 4 trial, researchers set out to test Triptorelin.

To prove that the use of GnHR agonist for final oocyte maturation results in a higher percentage of mature oocytes than the use of hCG. 2.

To show an advantage in women's satisfaction in the proposed protocol versus the standard antagonist protocol In the study group women will receive GnRH agonist for oocyte maturation, followed by ovum pick-up which will be performed 35 hours later.

Embryo transfer will be performed 48-72 hours after ovum pick-up.

It had 1 arm (groups): Gnrh agonist , hcg (experimental).

Gnrh agonist for final oocyte maturation, hcg for luteal support.

The registry classes the interventions as drug.

More on the Plan

Final Oocyte Maturation via Administration of GnRH Agonists Followed By Luteal Support with hCG The use of Gonadotropin-Releasing Hormone (GnRH) antagonists in in vitro fertilization (IVF) stimulation protocols holds many advantages over the long protocol with GnRH agonists.

One of the advantages includes the ability to use GnRH agnosits for final oocyte maturation, thus minimizing the risk of ovarian hyperstimulation syndrome.

For the purpose of this study, this response includes estradiol levels higher than 2500 pg/ml, fifteen or more follicles over 12 mm in diameter, or any other case in which the treating physician has reason to suspect an eventual hyperstimulation reaction.

Study Protocol: Informed consent will be obtained at the beginning of the treatment and up until the day of final oocyte maturation.

Who Took Part

The registry lists 93 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Patients who are eligible for in vitro fertilization using an antagonist protocol.

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Triptorelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2012-09 with completion listed for 2017-07.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: fertilization rate (time frame: 4 weeks).

It also tracked 1 secondary outcome, for example satisfaction, no. of oocyte, pregnancy rate, no. of embryos, quality of embryos.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Triptorelin in 93 people.

The trial is marked completed; 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.