Dual FSH/HCG Trigger in Letrozole Stimulated Intrauterine Insemination Cycles in Women With Unexplained Infertility

What Was Tested

In this phase 3 trial, researchers set out to test hCG (human chorionic gonadotropin).

The objective of this study was to evaluate the outcome of follicle stimulating hormone (FSH) co-administration with human chorionic gonadotrophins trigger for women with unexplained infertility (UEI) and assigned for letrozole (LTZ) stimulated intrauterine insemination (IUI) cycles .

It had two arms (groups): Control (active comparator) and Study (experimental).

The registry classes the interventions as drug.

More on the Plan

The study protocol was approved by the Local Ethics Committee and written informed consents were taken from both partners before starting of the study.

On the day of hCG administration women were randomly categorized into two groups according to a computer generated random numerical table.

Envelopes containing the allocation information were chosen sequentially by patient herself in presence of her husband.

Intrauterine insemination was performed 36 hours after HCG injection.

Who Took Part

108 actual participants took part.

It was open to women only aged from 18 years up to 35 years.

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

Examples of who could join: Unexplained infertility for more than 2 years. Normal ovulation proved by midluteal serum progesterone level \>5 ng/ml,. Patent fallopian tubes confirmed by hysterosalpingography or laparoscopy. Normal semen analysis according to the modified World Health Organization (WHO) criteria. Normal hormonal profile (FSH, LH, prolactin and TSH) in the early follicular phase.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: other causes of infertility ( tubal factors, polycystic ovary syndrome (pcos), endometriosis); ovarian cysts,; FSH \>10 mIU/ml.

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 hCG (human chorionic gonadotropin) and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label hCG (human chorionic gonadotropin) study: the participants and staff both knew the treatment.

It started in 2014-06 with completion listed for 2015-08.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Clinical pregnancy rate per cycle (PR/C) and per woman (PP/W) (time frame: Throughout the study completion; up to 3 months).

It also tracked 3 secondary outcomes, for example Frequency of ovarian hyperstimulation syndrome (OHSS), Multiple pregnancies and The live birth rate per woman (LB/W).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of hCG (human chorionic gonadotropin) in 108 people.

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

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.