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Status unknownNCT04178135Updated Jan 11, 2022

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

An interventional study of rLH and rLH in Infertility,Female, sponsored by Reproductive & Genetic Hospital of CITIC-Xiangya. Status unknown at 2 sites in China. Open to female participants aged 35 Months to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-11.

Sponsored by Reproductive & Genetic Hospital of CITIC-Xiangya · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
35 Months to 40 Years
Sex
Female
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Study 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.

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Conditions studied

  • Infertility,Female

Keywords

  • poor or suboptimal ovarian response,GnRH agonist long protocol
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In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 100 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Reproductive & Genetic Hospital of CITIC-Xiangya is the lead sponsor of 26 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Months to 40 Years
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    rLH supplementation from day 1 of stimulation

    rLH supplementation from day 1 of stimulation

    Drug: rLH

  • Active comparator
    rLH supplementation from day 6 of stimulation

    rLH supplementation from day 6 of stimulation

    Drug: rLH

Interventions

  • DrugrLH

    rLH supplement from day 1 of stimulation

  • DrugrLH

    rLH supplement from day 6 of stimulation

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What researchers measure

Primary outcomes

  1. Number of gestational sacs

    Number of gestation sac will be detected by ultrasonographic visualization

    Time frame: Day 28 after embryo transfer

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Study locations

2 of 2 sites recruiting
  • Reproductive & Genetic Hospital of CITIC-XIANGYA
    Changsha, Hunan 410000, China
    Recruiting
  • Reproductive & Genetic Hospital of CITIC-XIANGYA
    Changsha, Hunan 410008, China
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04178135
Lead sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
Responsible party
Sponsor
First posted
Nov 26, 2019
Start date
Dec 25, 2019
Primary completion
Dec 30, 2022 (estimated)
Completion
Dec 30, 2022 (estimated)
Last update
Jan 11, 2022

Study contacts

Sufen Cai, Doctor
Contact
ajiu0305@163.com
0731-82355100
Sufen Cai, Doctor
principal investigator · Reproductive and Genetic hospital of CITIC-xiangya

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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