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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-25

Study Completion Date

2022-12-30

Brief Summary

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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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Detailed Description

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Conditions

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Infertility,Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rLH supplementation from day 1 of stimulation

Group Type EXPERIMENTAL

rLH

Intervention Type DRUG

rLH supplement from day 1 of stimulation

rLH supplementation from day 6 of stimulation

Group Type ACTIVE_COMPARATOR

rLH

Intervention Type DRUG

rLH supplement from day 6 of stimulation

Interventions

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rLH

rLH supplement from day 1 of stimulation

Intervention Type DRUG

rLH

rLH supplement from day 6 of stimulation

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

35 Months

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes