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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    100
  • sponsor
    Reproductive & Genetic Hospital of CITIC-Xiangya
Updated on 21 March 2022
Accepts healthy volunteers

Summary

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.

Details
Condition Infertility,Female
Treatment rLH
Clinical Study IdentifierNCT04178135
SponsorReproductive & Genetic Hospital of CITIC-Xiangya
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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

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

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