Injection Free IVF

What Was Tested

This registered phase 2 trial tested Nafarelin.

It had two arms (groups): Intervention A: hCG injection (active comparator) and Intervention B: nasal application of Nafarelin (experimental).

The registry classes the interventions as drug.

More on the Plan

These kinds of IVF treatments are called Natural Cycle IVF (NC-IVF).

However, a relevant burden in NC-IVF still is the ovulation induction by self-injection of human Chorionic Gonadotropin (hCG).

GnRHa are already used to induce ovulation in classical IVF treatments.

The study will be a randomized controlled proof-of-concept trial.

Who Took Part

It was open to women only aged from 18 years up to 42 years.

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

Examples of who could join: Indication for IVF. Wish to perform NC-IVF. Regular menstruation cycles (26-32 days). Orthotopic localization of ovaries. Written informed consent.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: endometrioses iii°-iv°; ≥ 3 embryo transfers in previous ivf therapies without pregnancy; contraindications or allergies against study medications.

How the Study Was Run

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

Because people in this Nafarelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Nothing was hidden in this open-label Nafarelin study: the participants and staff both knew the treatment.

It started in 2021-05-01 with completion listed for 2024-03-31.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Treatment tolerability. Discomfort of treatment.

It also tracked 1 secondary outcome, for example Embryo transfer rate.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Nafarelin in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Nafarelin compound page, all human trials.