Recombinant LH Supplementation Timing Strategies (From Day 1 or Day 6) to a Standard GnRH Agonist Long Protocol in Subsequent COS Cycle of Older Patients With Unexpected Poor or Suboptimal Ovarian Response

January 10, 2022 updated by: Reproductive & Genetic Hospital of CITIC-Xiangya
A randomized, controlled, pilot study, for Patients ≥ 35 years and < 40 years old with sufficient ovarian reserve parameters (AFC≥ 5), but showed an unexpected poor or suboptimal ovarian response(defined as ≤ 9 retrieved oocytes in previous full-stimulation cycle, but not get live birth after all embryos were used ). In order to get better oocyte number and quality in the new COS cycle, we will compare LH supplementation from beginning with from middle of stimulation in GnRH-a long protocol.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410000
        • Recruiting
        • Reproductive & Genetic Hospital of Citic-Xiangya
        • Contact:
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Reproductive & Genetic Hospital of Citic-Xiangya
        • Contact:

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

2 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

1.Infertile women, 35≤ Age< 40 years 2.18<BMI<28 Kg/m2 3.5 ≤AFC ≤20 4.Basal serum FSH≤10 IU/L, E2<70 pg/ml 5.Previous cycle as the first COS cycle,AFC ≥ 5,starting dose of FSH between 150 IU and 300IU with the possibility of adding r-hLH or hMG later in the cycle, number of oocytes retrieved ≤9 (4-9 oocytes retrieval as suboptimal responder and <4 oocytes retrieval as unexpected poor responder), but not get live birth after all embryos were used.

6.Normal uterus and at least one side of the normal ovary 7.GnRH-a long protocol, using Gonal-F® 300IU and Luveris® 150IU for COS 8.Informed consent form signed 9.Willing to follow the study protocol, and able to complete this study

Exclusion Criteria:

  1. Moderate and Severe endometriosis
  2. PCOS
  3. Previous ovarian surgery history
  4. History of recurrent miscarriages (>2 times of miscarriages)
  5. Any major systemic disease that as per Investigator's discretion precludes subject for participation in the study
  6. With pregnancy contraindications Alcoholism, drug abuse, drug addiction or patients with uncured sexually transmitted disease
  7. According to the judgment of the Investigator, any medical condition or any concomitant surgery/medications that would interfere with evaluation of study medications
  8. Simultaneous participation in another clinical study
  9. Plan to use other Gn other than Gonal-F® or Luveris® during COS treatment Thyroid gland disorders

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rLH supplementation from day 1 of stimulation
Drug: rLH
rLH supplement from day 1 of stimulation
Drug: rLH
rLH supplement from day 6 of stimulation
Active Comparator: rLH supplementation from day 6 of stimulation
Drug: rLH
rLH supplement from day 1 of stimulation
Drug: rLH
rLH supplement from day 6 of stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of gestational sacs
Time Frame: Day 28 after embryo transfer
Number of gestation sac will be detected by ultrasonographic visualization
Day 28 after embryo transfer

Collaborators and Investigators

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

Sponsor

Reproductive & Genetic Hospital of CITIC-Xiangya

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 (Actual)

December 25, 2019

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

November 24, 2019

First Submitted That Met QC Criteria

November 24, 2019

First Posted (Actual)

November 26, 2019

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 10, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P2019005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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