A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 for In Vitro Fertilization

A Phase 3, Single-Blind, Randomized Study to Compare DR-2011 to a Progesterone Gel for Luteal Phase Supplementation for In Vitro Fertilization

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00615251

Enrollment

1297

Registered

2008-02-14

Start date

2008-02-29

Completion date

2009-08-31

Last updated

2013-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

In vitro fertilization

Brief summary

This is a multi-center study to evaluate the effects of DR-2011 compared to a progesterone gel in women undergoing in vitro fertilization with fresh eggs. The overall study duration will be approximately 12 months and will involve ovarian suppression/stimulation protocols as well as egg retrieval.

Interventions

DRUGDR-2011

Progesterone vaginal ring for approximately 10 weeks

DRUGCrinone 8%

progesterone vaginal gel for approximately 10 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 42 Years

Healthy volunteers

Yes

Inclusion criteria

* Pre-menopausal, aged 18-42 old at time of consent * At least one cycle without fertility medication prior to screening * Tubal, idiopathic, male factor, ovulatory dysfunction or endometriosis- linked infertility * Semen analysis (frozen sperm, including donor sperm, may be used, as long as testing done at time of freezing meets standard criteria) * Others as indicated by FDA-approved protocol

Exclusion criteria

* Any contraindication to progesterone therapy * BMI \> 38 kg/m2 * Clinically significant gynecologic pathology (for example: submucosal fibroids, abnormal uterine cavity, or others) * History of more than 1 failed fresh IVF cycles * More than 2 consecutive clinical miscarriages (gestational sac observed on ultrasound) * Others as indicated by FDA-approved protocol

Design outcomes

Primary

Measure	Time frame
Clinical pregnancy rate at 8 weeks and 12 weeks of pregnancy	8 weeks of pregnancy (6 weeks after egg retrieval) and 12 weeks of pregnancy (10 weeks after egg retrieval)

Secondary

Measure	Time frame
Secondary outcome measures will include: live birth rate, cycle cancellation rate, rate of spontaneous abortion, rate of biochemical pregnancy, rate of ectopic pregnancy	Duration of study
Adverse events	Duration of study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026