Trial intelligence / Profile preview

Growth Hormone Supplementation in IVF/ICSI for Poor Responders

NCT03759301Phase 4

Key facts

Status: Completed
Start: Dec 2018
Primary completion: May 2019
Countries: 1
Sponsor: ClinAmygate
Modality: Hormone, rProtein (Recombinant Protein), Biologic

Drugs: somatropin
Conditions: female infertility

Overview

Phase 4, randomised, double-blind trial in female infertility comparing Somatropin Group with Placebo Group (2 arms). Primary endpoint: clinical pregnancy rate at 3 weeks. Started Dec 2018; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Somatropin Group
Somatropin 4 IU/day SC + Standard COS
Placebo Group
Placebo SC + Standard COS

Endpoints

Primary

clinical pregnancy rate3 weeks

Secondary

E2 levelsDay of HCG injection
Number of oocytes collectedDay 6 of COS
Metaphase I (MI) and Metaphase II (MII) oocyte numberDay 6 of COS
Number of PronucleusDay 6 of COS
Multiple pregnancy6 weeks from last period

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