Protocol to Minimize Injections and Blood Draws for Women Undergoing in Vitro Fertilization

What Was Tested

This registered not phased trial tested HMG (Human Menopausal Gonadotropin) and Nafarelin.

The purpose of this study is also to report and monitor any and all side effects of the nasal Menopur.

It had two arms (groups): Conventional IVF (active comparator) and IVF protocol using nasal gonadotropins (experimental).

The registry classes the interventions as drug.

More on the Plan

During a regularly occurring menstrual cycle, both FSH and LH are produced by the pituitary gland in the brain to naturally stimulate the ovaries to make a single egg each month.

Injections of gonadotropins are started early (usually on the third day) in the menstrual cycle to cause multiple eggs to grow to a mature size.

Close monitoring of patients with ultrasound and blood are usually needed for monitoring.

The ultrasound measures the size of the ovarian follicles.

Who Took Part

The registry lists 4 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Age range: 18-45. The participant should be a woman of reproductive age, i.e., premenopausal who is healthy. Body mass index: 19-35 kg/m2. Pap smear within 1 year should be normal. Endometrial cavity will be evaluated and should be normal using hysteroscopy or saline ultrasound. Semen analysis will be performed on every male partner to ensure that there are sperm to be used for IVF/ICSI.

The full record lists 9 inclusion and 4 exclusion criteria; among the exclusions: any medical condition that interferes with the health of the participant such as uncontrolled diabetes, uncontrolled hypertension, cardiac disease, or renal disease; any type of malignancy; mental problems that could interfere with the patient's ability to conceive and take care of her baby.

How the Study Was Run

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

The HMG (Human Menopausal Gonadotropin) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label HMG (Human Menopausal Gonadotropin) study: the participants and staff both knew the treatment.

It started in 2016-07-01 with completion listed for 2017-06-07.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Serum estradiol level (time frame: 1 year). Ovarian follicular size (time frame: 1 year).

It also tracked 1 secondary outcome, for example Adverse Events That Are Related to Nasal Menopur Treatment.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of HMG (Human Menopausal Gonadotropin) and Nafarelin in 4 people.

Its size is small, so on its own it can only give an early look.

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 and the Nafarelin compound page, all human trials.