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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Infertility,Female

Intervention / Treatment
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* Drug: rLH
* Drug: rLH


Participation Criteria
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Eligibility Criteria
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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: 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 According to the judgment of the Investigator, any medical condition or any concomitant surgery/medications that would interfere with evaluation of study medications Simultaneous participation in another clinical study Plan to use other Gn other than Gonal-F® or Luveris® during COS treatment Thyroid gland disorders

Ages Eligible for Study
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Minimum Age: 35 Months
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rLH supplementation from day 1 of stimulation<br>rLH supplementation from day 1 of stimulation | Drug: rLH<br>* rLH supplement from day 1 of stimulation<br>|
| Active Comparator: rLH supplementation from day 6 of stimulation<br>rLH supplementation from day 6 of stimulation | Drug: rLH<br>* rLH supplement from day 6 of stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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poor or suboptimal ovarian response,GnRH agonist long protocol