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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

Primary Purpose

Infertility,Female

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
rLH
rLH
Sponsored by
Reproductive & Genetic Hospital of CITIC-Xiangya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility,Female focused on measuring poor or suboptimal ovarian response,GnRH agonist long protocol

Eligibility Criteria

35 Months - 40 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Reproductive & Genetic Hospital of CITIC-XIANGYARecruiting
  • Reproductive & Genetic Hospital of CITIC-XIANGYARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

rLH supplementation from day 1 of stimulation

rLH supplementation from day 6 of stimulation

Arm Description

rLH supplementation from day 1 of stimulation

rLH supplementation from day 6 of stimulation

Outcomes

Primary Outcome Measures

Number of gestational sacs
Number of gestation sac will be detected by ultrasonographic visualization

Secondary Outcome Measures

Full Information

First Posted
November 24, 2019
Last Updated
January 10, 2022
Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
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1. Study Identification

Unique Protocol Identification Number
NCT04178135
Brief 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
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 25, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility,Female
Keywords
poor or suboptimal ovarian response,GnRH agonist long protocol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rLH supplementation from day 1 of stimulation
Arm Type
Experimental
Arm Description
rLH supplementation from day 1 of stimulation
Arm Title
rLH supplementation from day 6 of stimulation
Arm Type
Active Comparator
Arm Description
rLH supplementation from day 6 of stimulation
Intervention Type
Drug
Intervention Name(s)
rLH
Intervention Description
rLH supplement from day 1 of stimulation
Intervention Type
Drug
Intervention Name(s)
rLH
Intervention Description
rLH supplement from day 6 of stimulation
Primary Outcome Measure Information:
Title
Number of gestational sacs
Description
Number of gestation sac will be detected by ultrasonographic visualization
Time Frame
Day 28 after embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Months
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sufen Cai, Doctor
Phone
0731-82355100
Email
ajiu0305@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sufen Cai, Doctor
Organizational Affiliation
Reproductive and Genetic hospital of CITIC-xiangya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reproductive & Genetic Hospital of CITIC-XIANGYA
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sufen Cai, doctor
Phone
0731-82355100
Email
ajiu0305@163.com
Facility Name
Reproductive & Genetic Hospital of CITIC-XIANGYA
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sufen Cai, doctor
Phone
0731-82355100
Email
ajiu0305@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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