To Describe the Effect of rhLH Supplementation in Women With Hyporesponse to rhFSH After Pituitary Downregulation

December 9, 2009 updated by: Peking University Third Hospital

A Multicentre, Prospective, Open Study to Describe the Effects of rhLH Supplement in Women With Hyporesponse to rFSH After Pituitary Downregulation.

Primary objective:

To evaluate the efficacy in terms of oocyte retrieval number of rLH supplement in women with hyporesponse to rFSH after pituitary downregulation.

Secondary objective:

To further explore the efficacy of rLH supplement in women with hyporesponse to rFSH after pituitary downregulation To evaluate the safety of rLH supplementation in hyporesponse women

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Primary endpoint:

Number of oocyte retrieved

Secondary endpoints:

  1. Oestrodial on hCG day (pg/ml)
  2. Number of embryos
  3. Implantation rate (%)
  4. Clinical pregnancy rate (%)
  5. Ongoing PR per IVF cycle (%)
  6. Abortion rate (%)
  7. Ampoules of rFSH
  8. FertiQoL score Safety endpoint: adverse events

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. 20-40 years old women
  2. With menstrual cycles ranged 24-35 days, intraindividual variability±3 days
  3. Basal FSH <10 IU/L at cycle D2-D5
  4. 18 < BMI < 30
  5. Presence of two ovaries
  6. No ovarian stimulation over the past 3 months
  7. Signed inform consent form.

Exclusion Criteria:

  1. Polycystic ovarian syndrome
  2. rAFS stage Ⅲ-Ⅳ endometriosis
  3. Chromosomal abnormalities, endocrinological and/or autoimmune disorders.
  4. More than two previously unsuccessful IVF.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Luveris
Those subjects who experience hyponresponse to FSH stimulation during mid-follicle phase after pituitary downregulation will receive Luveris 75IU or 150IU IH injection daily till HCG day.
Drug: Luveris
Luveris 75IU or 150IU depending on the patient conditions, subcutaneous injection, Qd, from Day 8 till hCG Day
Other Names:
  • Gonal-f, ovidrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of oocyte retrieved
Time Frame: 2009Dec-2010Oct
2009Dec-2010Oct

Secondary Outcome Measures

Outcome Measure
Time Frame
1. Oestrodial on hCG day (pg/ml) Safety: adverse events
Time Frame: 2009 Dec-2010 Oct
2009 Dec-2010 Oct
2. Number of embryos
Time Frame: 2009 Dec-2010 Oct
2009 Dec-2010 Oct
3. Implantation rate (%)
Time Frame: 2009 Dec-2010 Oct
2009 Dec-2010 Oct
4. Clinical pregnancy rate (%)
Time Frame: 2009 Dec-2010 Oct
2009 Dec-2010 Oct
5. Ongoing PR per IVF cycle (%)
Time Frame: 2009 Dec-2010 Oct
2009 Dec-2010 Oct
6. Abortion rate (%)
Time Frame: 2009 Dec-2010 Oct
2009 Dec-2010 Oct
7. Ampoules of rFSH
Time Frame: 2009 Dec-2010 Oct
2009 Dec-2010 Oct
8. FertiQoL score Safety: adverse events
Time Frame: 2009 Dec-2010 Oct
2009 Dec-2010 Oct

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Collaborators

Peking Union Medical College Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Reproductive & Genetic Hospital of CITIC-Xiangya
Chongqing Medical Center for Women and Children

Investigators

  • Principal Investigator: Jie Qiao, MD, PhD, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Anticipated)

October 1, 2010

Study Completion (Anticipated)

March 1, 2011

Study Registration Dates

First Submitted

December 9, 2009

First Submitted That Met QC Criteria

December 9, 2009

First Posted (Estimate)

December 10, 2009

Study Record Updates

Last Update Posted (Estimate)

December 10, 2009

Last Update Submitted That Met QC Criteria

December 9, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR700642-606

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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