Study on Influence of Leutinizing Hormone (LH) on Oocyte Maturity

What Was Tested

In this not phased trial, researchers set out to test Cetrorelix.

In early follicular phase,in the requisite range,LH is known to contribute to maturation of oocyte during transition phase from metaphase-1(M1) to metaphase-2 (M2). 3.

If during this transition, appropriate level of LH can be maintained either through the use of gonadotropin releasing hormone (GnRH) antagonist if found excessive or supplementation with exogenous LH, if found deficient, maturation process can be enhanced. 4.

It had two arms (groups): Study subjects desiring pregnancy (active comparator) and Control subjects desiring pregnancy (other).

The registry classes the interventions as drug.

More on the Plan

The study is planned to assess whether maintenance of levels of LH through the use of GnRH antagonist would contribute to obtaining mature M2 oocytes so that maximum number of good quality embryo's with potential to implant is obtained.

The mature oocytes would be subjected to either standard in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) depending on the status of the male factor.

The objective would be to obtain good quality embryo's with implantation potential for fresh embryo transfer and/or subsequent frozen thaw embryo transfer.

In both these events, the secondary outcome measures would be establishment of clinical pregnancy by transvaginal ultrasound performed 6 weeks after embryo transfer.

Who Took Part

Enrollment: 300 planned participants were the target.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: Women aged 18-40 years. Desire to achieve pregnancy. Basal FSH \<12 mIU/ML. Moderate to good ovarian reserve (antimullerian hormone (AMH) \>1ng/ml, and/ or antral follicle count (AFC)\>8 between both ovaries). Informed written consent from both partners.

The full record lists 8 inclusion and 5 exclusion criteria; among the exclusions: hormonal preparation taken within 3 month prior to recruitment; women with previous poor response to gonadotrophins; history of previous 3 or more miscarriages.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Cetrorelix 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 Cetrorelix study did not mask who received what.

It started in 2012-04 with completion listed for 2012-09.

It ran at 3 sites in India (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of mature oocytes immediately after oocyte recovery (time frame: Women would be followed every 2 weeks upto 6 weeks after embryo transfer).

It also tracked 1 secondary outcome, for example Clinical pregnancy.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cetrorelix in 300 people.

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

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