Clinical trial NCT04178135: 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
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility,Female
Keywords: poor or suboptimal ovarian response,GnRH agonist long protocol
Lead sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of gestational sacs
timeFrame: Day 28 after embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Reproductive & Genetic Hospital of CITIC-XIANGYA
state: Hunan
city: Changsha
country: China
facility: Reproductive & Genetic Hospital of CITIC-XIANGYA
state: Hunan
Study officials:
affiliation: Reproductive and Genetic hospital of CITIC-xiangya
name: Sufen Cai, Doctor
role: PRINCIPAL_INVESTIGATOR
References: