Letrozole Alone Protocol Versus Using Letrozole and HCG Protocol

What Was Tested

This registered phase 1 trial tested hCG (human chorionic gonadotropin) for pcos.

Letrozole is a chemical compound, CGS 20267 which is a third-generation, nonsteroidal aromatase inhibitor.

It had two arms (groups): Group A: letrozole only (active comparator) and Group B: letrozole + HCG (active comparator).

About 66 Patients took Letrozole drug only for induction of ovulation at the time of suspected ovulation maturity.

About 66 Patients took Letrozole drug in addition to HCG for induction of ovulation at the time of suspected ovulation maturity.

The registry classes the interventions as drug.

More on the Plan

The first pilot study for the clinical use of letrozole for ovarian induction in polycystic ovary syndrome (PCOS) patients was done in 2000.

Human chorionic gonadotropin (HCG) hormone will replace the naturally surging luteinizing hormone at mid-cycle, subsequently, will lead to full maturation of oocytes resulting in ovulation.

Additionally, HCG will also enhance the endometrial quality by stimulating the corpus luteum.

HCG is a hormone that is produced mainly by the placental syncytiotrophoblasts cells, it is also produced by other organs in minute amounts (Liver, colon and pituitary gland).

Who Took Part

132 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: Infertile women with PCOS. Normal semen analysis according to WHO parameters are major prerequisites.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: infertile women with causes other than pcos,; ages \<18 or \>35 years; women taken confounding medications like other infertility drugs.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

The pcos participants were allocated by chance, so the hCG (human chorionic gonadotropin) group and the comparison group should start out alike.

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

Only one side, usually the pcos participants, was kept unaware of whether hCG (human chorionic gonadotropin) was given.

Those kept unaware of assignments: participant.

It started in 2022-11-10 with completion listed for 2023-11-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Pregnancy test (time frame: 2 weeks after ovulation).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of hCG (human chorionic gonadotropin) in 132 people with pcos.

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, PCOS research.