Poor Ovarian Stimulation Response in In Vitro Fertilization (IVF) Program

What Was Tested

The trial (early phase 1) is built around Cetrorelix.

It had two arms (groups): Poor responders (active comparator) and Good responders (active comparator).

The registry classes the interventions as drug.

More on the Plan

In-vitro fertilization treatment safety is highly challenged by the erratic individual variability to controlled ovarian hyperstimulation (COH).

One of the diverse predictive factors is the AMH, which is considered to be the most sensitive marker.

Materials and Methods: Starting June 2013, couples with unexplained infertility, seeking the first attempt IVF/ICSI treatment cycle will be recruited in "AL shark Al-Awsat fertility center".In this prospective study, 216 Couples fulfilling their inclusion criteria will enroll in this study after informed consent.

According to their primary outcome, the number of oocytes collected, patients will be classified as poor responders (4 oocytes or less) and will be considered as good responders if they produced 5 or more oocytes.

Who Took Part

Enrollment: 216 actual participants took part.

It was open to women only aged from 25 years up to 35 years.

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

Examples of who could join: Women at or under the age of 35 years. Normal thyroid stimulating hormone and prolactin levels. Normal ovulatory cycles (25-35 interval days), together with proven patent fallopian tubes at hysterosalpingography or laparoscopy done within six cycles preceding the ICSI cycle. Presence of both ovaries with normal findings as assessed by trans-vaginal ultrasound and laparoscopy. All male partners had a normal semen analysis according to WHO criteria (WHO, 2010), done within 6 months preceding the ICSI cycle.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: chronic medical disorders such as diabetes; previous inadequate response to ovulation induction; polycystic ovary syndrome.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

The Cetrorelix group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Cetrorelix study: the participants and staff both knew the treatment.

It started in 2013-06 with completion listed for 2015-06.

Its stated primary purpose is screening.

What Was Measured

Researchers chose this as the main measure: number of oocytes collected (time frame: 3 weeks from of start of ICSI cycle).

What This Means in Plain Language

Put simply, this is a early phase 1, non-randomized trial of Cetrorelix in 216 people.

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

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