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A Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Intravaginal Micronized Progesterone Capsules 600 mg Daily for Luteal Support in In-Vitro Fertilization

NCT01850030 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1070

Last updated 2018-01-02

Study results available
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Summary

Female inability to conceive a child. The purpose of this randomized, two-arm and double blind, double dummy study is to demonstrate that the treatment of a daily dose of 3x10mg dydrogesterone orally is as effective and safe as the daily dose of 3x200 mg micronized progesterone capsules administered intravaginally for the luteal support in patients undergoing IVF. The treatment will start on the day of oocyte retrieval and continue until pregnancy is negative or until week 12 gestation.Patients will be followed after treatment until 30 days after delivery to record any safety and tolerability data of the patient and their newborn(s).

Conditions

  • Female Infertility

Interventions

DRUG

Dydrogesterone 30 mg

Oral Dydrogesterone 10 mg tablets tid

DRUG

Micronized Progesterone 600 mg

Intravaginal micronized progesterone 200 mg capsules tid

DRUG

Placebo progesterone

Placebo intravaginal micronized progesterone 200 mg capsules tid

DRUG

Placebo dydrogesterone

placebo oral dydrogesterone 10 mg tablets tid

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Abbott

    lead INDUSTRY

Principal Investigators

  • Darline Cheatham-Seitz, MD, PhD · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
41 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Austria
  • Belgium
  • Finland
  • Germany
  • Israel
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01850030 on ClinicalTrials.gov