Clinical Study of Recombinant Human Follitropin for Injection Assisted in COH Assisted IVF-ET

What Was Tested

The trial (phase 3) is built around hCG (human chorionic gonadotropin) and Triptorelin.

It had two arms (groups): Recombinant Human Follitropin (experimental) and Gonal-F (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 252 planned participants were the target.

It was open to women only aged from 20 years up to 39 years.

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

Examples of who could join: Age is more than 20 years old and less than 39 years old, married. Applicable for ART controlled ovarian hyperstimulation, such as IVF/ET, ICSI, GIFT, ZIFT and so on. Regular menstrual cycle (25-35 days). Volunteer to participate and sign informed consent.

The full record lists 8 inclusion and 14 exclusion criteria; among the exclusions: the subject has abnormal uterine bleeding; affect pregnancy-related endocrine and metabolic diseases (any one): hyperprolactinemia, thyroid disease (including hyperthyroidism, hypothyroidism), hyperandrogenism, adrenal dysfunction (including adrenal hyperfunction, adrenal cortical dysfunction); the subject who have contraindications or allergic history for gonadotropin-releasing hormone agonists (gnrh-a), rfsh/human menopausal gonadotropin (hmg), human chorionic gonadotropin (hcg), progesterone drugs.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

The 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 participants stayed in one arm throughout.

As a double-blind hCG (human chorionic gonadotropin) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2017-03 with completion listed for 2017-12.

It ran at 7 sites in China (7).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The total number of oocytes obtained during the start-up period (time frame: On the days of ovum picking up (hCG trigger 36-38h)).

It also tracked 18 secondary outcomes, for example The number of follicle-1, The number of follicle-2, Number of 2PN oocytes, Number of metaphase II oocytes, Number of transferred embryos and Number of high quality embryos.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of hCG (human chorionic gonadotropin) and Triptorelin in 252 people.

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

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