Mono-menotropins Versus rFSH Protocol on Embryo Quality

What Was Tested

The trial (not phased) is built around HMG (Human Menopausal Gonadotropin).

This study is for couples pursuing in vitro fertilization (IVF) with preimplantation genetic screening (PGS) of embryos to achieve pregnancy.

The objective of this clinical trial is to study the effect of mono-menotropins for COS versus recombinant follicle stimulating hormone (rFSH) on cleavage-stage and blastocyst embryo quality after IVF.

Embryo quality parameters include conventional embryo grade, early embryo viability assessment (Eeva) time-lapse parameters, and chromosomal aneuploidy rates after PGS.

It had two arms (groups): Mono-menotropin protocol (experimental) and rFSH protocol (experimental).

The registry classes the interventions as drug.

More on the Plan

Pre-medication All study patients will take oral contraception pills (OCP) starting between day 2-4 of the menstrual cycle before controlled ovarian stimulation (COS) is started for IVF, and they are continued for 21 days.

Randomization Randomization of patients into the Stimulation Group 1 (Mono-Menotropin Protocol) or Stimulation Group 2 (rFSH) will occur at OCP start using a computerized randomization program.

Menopur and Gonal-f are widely used in controlled ovarian stimulation cycles for the development of multiple follicles in assisted reproductive technology (ART) programs.

HCG Trigger Human chorionic gonadotropin (hCG) will be used intramuscularly (IM) in both stimulation groups to induce oocyte maturation 36 hours prior to the oocyte retrieval procedure Cycle Monitoring Cycles will be monitored with follicular ultrasound measurements and serum estradiol concentrations throughout ovarian stimulation.

Who Took Part

The registry lists 109 actual participants took part.

It was open to women only aged from 21 years up to 38 years.

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

Examples of who could join: Patients undergoing IVF in an attempt to achieve pregnancy. Antimullerian Hormone \> 1.5. Between 10 and 20 basal antral follicles on day 2-4 of the menstrual cycle. Body weight \>50 kg, with BMI \> 18 and \< 32 kg/m2.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: polycystic ovarian disease; endometriosis greater than stage i; testicular aspirated sperm.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got HMG (Human Menopausal Gonadotropin) and who got the comparison, which limits bias.

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

Being open-label, the HMG (Human Menopausal Gonadotropin) study did not mask who received what.

It started in 2015-03 with completion listed for 2017-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Embryo Quality (time frame: Embryo quality will be assessed on day 3, 5 and 6 of culture).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of HMG (Human Menopausal Gonadotropin) in 109 people.

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

More context: the HMG (Human Menopausal Gonadotropin) compound page, all human trials.