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The effect of recombinant Luteinizing Hormone (LH) supplementation in controlled ovarian hyperstimulation outcome in women with low LH concentration during mid- and late-follicular phase: a single-center, prospective, randomized controlled study

The effect of recombinant Luteinizing Hormone (LH) supplementation in controlled ovarian hyperstimulation outcome in women with low LH concentration during mid- and late-follicular phase: a single-center, prospective, randomized controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043606
Enrollment
Unknown
Registered
2021-02-23
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Interventions

rFSH :rFSH
rFSH+rLH :rFSH+rLH

Sponsors

West China Second Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 35 Years

Inclusion criteria

Inclusion criteria: The study population included patients who were treated in the reproductive medicine center of the second West China Hospital from March 2021 to March 2022 and who were treated with GnRH antagonist for the first time in IVF / ICSI, with basal FSH 4; BMI 18 ~ 28KG / m2. None of these patients had a history of recurrent failure (patients with more than 2 cycles) or recurrent implant failure. Serum LH <= 4IU/L (follicle diameter reached 12mm) was selected as the threshold standard. According to the following criteria, the subjects were randomly divided into two groups: the experimental group added rLH when the diameter of follicle reached 12mm, and the control group only used FSH: 1. In IVF / ICSI subjects treated with GnRHa antagonist of r-hFSH, LH <= 4iu / L; 2. Female subjects between 20 and 35 years old; 3. Subjects whose uterine cavity can maintain embryo implantation or pregnancy; 4. There are no known subjects infected with HIV, hepatitis B or C virus and other infectious diseases unsuitable for pregnancy; 5. Subjects willing to participate and comply with the protocol during the study; 6. Subjects who had obtained informed consent prior to any procedure related to the study and knew that the treatment was not a routine medical service.

Exclusion criteria

Exclusion criteria: 1. Repeated implantation failure (3 or more embryo transfers or more than 4 high-quality embryos in total, all failed to get pregnant); 2. Repeated failure of promoting ovulation (the previous cycle of promoting ovulation was more than 2 times); 3. Endocrine disorders such as PCOS, hypothalamus hypophysis, or ovarian dysfunction such as dor patients; 4. Subjects with clinically significant systemic diseases (e.g., insulin-dependent diabetes, epilepsy, severe migraine, intermittent porphyria, liver, kidney or cardiovascular disease, severe corticosteroid dependent asthma); 5. Any contraindications to pregnancy and / or childbirth; 6. The abnormal source of gynecological bleeding was unknown; 7. Subjects allergic to gonadotropin preparations; 8. Subjects in any medical condition prohibited from using gonadotropin preparations; 9. Subjects who have participated in this study or another clinical drug trial at the same time; 10. Subjects with any active substance abuse or history of drug, drug or alcohol abuse in the past 5 years; 11. Subjects who refused or were unable to comply with the protocol.

Design outcomes

Primary

MeasureTime frame
number of oocytes retrieved;number of embryos available;

Secondary

MeasureTime frame
M? oocyte;good quality embryos;clinical pregnancy rate of fresh embryo transfer cycle;ongoing pregnancy rate;clinical pregnancy rate on the first embryo transfer;occurring rate of ovarian hyperstimulation syndrome;

Countries

China

Contacts

Public ContactTian Tang

West China Second Hospital, Sichuan University

tangsisley@163.com+86 18628157383

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026