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

Infertility,Female Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04178135
• Other study ID #: P2019005
• Status: Recruiting
• Phase: N/A
• Start date: December 25, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2022
• Source: Reproductive & Genetic Hospital of CITIC-Xiangya
• Contact: Sufen Cai, Doctor
• Phone: 0731-82355100
• Email: ajiu0305[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Months to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Infertility,Female

Intervention

Drug:
• rLH
rLH supplement from day 1 of stimulation
• rLH
rLH supplement from day 6 of stimulation

Locations

Country	Name	City	State
China	Reproductive & Genetic Hospital of CITIC-XIANGYA	Changsha	Hunan
China	Reproductive & Genetic Hospital of CITIC-XIANGYA	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive & Genetic Hospital of CITIC-Xiangya

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of gestational sacs	Number of gestation sac will be detected by ultrasonographic visualization	Day 28 after embryo transfer