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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

Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya (Other)
Overall Status
Recruiting
CT.gov ID
NCT04178135
Collaborator
(none)
100
Enrollment
2
Locations
2
Arms
36.2
Anticipated Duration (Months)
50
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 25, 2019
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: rLH supplementation from day 1 of stimulation

rLH supplementation from day 1 of stimulation

Drug: rLH
rLH supplement from day 1 of stimulation
Active Comparator: rLH supplementation from day 6 of stimulation

rLH supplementation from day 6 of stimulation

Drug: rLH
rLH supplement from day 6 of stimulation

Outcome Measures

Primary Outcome Measures

  1. Number of gestational sacs [Day 28 after embryo transfer]

    Number of gestation sac will be detected by ultrasonographic visualization

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Months to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Reproductive & Genetic Hospital of CITIC-XIANGYA Changsha Hunan China 410000
2 Reproductive & Genetic Hospital of CITIC-XIANGYA Changsha Hunan China 410008

Sponsors and Collaborators

  • Reproductive & Genetic Hospital of CITIC-Xiangya

Investigators

  • Principal Investigator: Sufen Cai, Doctor, Reproductive and Genetic hospital of CITIC-xiangya

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Reproductive & Genetic Hospital of CITIC-Xiangya
ClinicalTrials.gov Identifier:
NCT04178135
Other Study ID Numbers:
  • P2019005
First Posted:
Nov 26, 2019
Last Update Posted:
Jan 11, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Reproductive & Genetic Hospital of CITIC-Xiangya
poor or suboptimal ovarian response,GnRH agonist long protocol
Additional relevant MeSH terms:
Infertility
Infertility, Female

Study Results

No Results Posted as of Jan 11, 2022