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

Not Applicable

• Conditions: Infertility,Female
• Interventions: Drug: rLH

• Registration Number: NCT04178135
• Lead Sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-24
• Study First Submitted QC: 2019-11-24
• Study First Posted: 2019-11-26
• Study Start: 2019-12-25
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-10
• Last Update Posted: 2022-01-11
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rLH supplementation from day 1 of stimulation	rLH	rLH supplementation from day 1 of stimulation
rLH supplementation from day 6 of stimulation	rLH	rLH supplementation from day 6 of stimulation

Primary Outcome Measures

Name	Time	Method
Number of gestational sacs	Day 28 after embryo transfer	Number of gestation sac will be detected by ultrasonographic visualization

Trial Locations

Locations (1)

Reproductive & Genetic Hospital of CITIC-XIANGYA; 🇨🇳 Changsha, Hunan, China