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

NCT04178135 | Unknown

• 1 other identifier: P2019005
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Infertility,Female

Keywords

poor or suboptimal ovarian response,GnRH agonist long protocol

Outcome Measures

Primary Outcomes (1)

• Number of gestational sacs

  Number of gestation sac will be detected by ultrasonographic visualization

  Day 28 after embryo transfer

Study Arms (2)

rLH supplementation from day 1 of stimulation

EXPERIMENTAL

rLH supplementation from day 1 of stimulation

Drug: rLH

rLH supplementation from day 6 of stimulation

ACTIVE COMPARATOR

rLH supplementation from day 6 of stimulation

Drug: rLH

Interventions

rLH DRUG

rLH supplement from day 1 of stimulation

rLH supplementation from day 1 of stimulation

Eligibility Criteria

• Age: 35 Months - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reproductive & Genetic Hospital of CITIC-Xiangya: lead

Study Sites (2)

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, 410000, China

RECRUITING

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, 410008, China

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Sufen Cai, Doctor

  Reproductive and Genetic hospital of CITIC-xiangya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sufen Cai, Doctor

CONTACT

0731-82355100; ajiu0305@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2019
• First Posted: November 26, 2019
• Study Start: December 25, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

CN (2)