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Efficacy and Safety of QL1012 in Women for Assisted Reproductive Treatment

NCT ID: NCT05149924

Last Updated: 2021-12-08

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

354 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-31

Study Completion Date

2019-10-17

Brief Summary

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The study is conducted to confirm equivalence between QL1012 (a new biosimilar formulation of Recombinant Human Follicle-stimulating Hormone) and Gonal-f® with respect to the number of oocytes retrieved in women for assisted reproductive treatment.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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QL1012，Recombinant Human Follicle Stimulating Hormone for Injection

Group Type EXPERIMENTAL

QL1012

Intervention Type DRUG

Subcutaneous injection,starting dose within 75IU \~ 300IU determined by the age , maximum daily dose 450IU

Gonal-f ®

Group Type ACTIVE_COMPARATOR

Gonal-f ®

Intervention Type DRUG

Subcutaneous injection,starting dose within 75IU \~ 300IU determined by the age , maximum daily dose 450IU

Interventions

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QL1012

Subcutaneous injection,starting dose within 75IU \~ 300IU determined by the age , maximum daily dose 450IU

Intervention Type DRUG

Gonal-f ®

Subcutaneous injection,starting dose within 75IU \~ 300IU determined by the age , maximum daily dose 450IU

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Signed informed consent
2. Aged 20 \~ 39 years(inclusive)
3. Body mass index (BMI) between 18\~30 kg/m2(inclusive)
4. Regular menstrual cycle (25\~35 days)
5. Basal FSH \< 10 IU/L (menstrual cycle day 2\~5)

Exclusion Criteria

1. History of ≥3 previously completed IVF/ICSI-ET cycles without clinical pregnancy
2. History of ≥3 recurrent spontaneous miscarriages
3. Patients with high risk of ovarian hyperstimulation syndrome (OHSS)
4. Primary ovarian failure or poor responders to ovarian stimulation
5. Presence of pregnancy in previous 3 months
6. Presence of clinically significant systemic disease, endocrine disease or metabolic abnormalities
7. History of malignant tumors of the ovary, breast, uterus, hypothalamus, pituitary gland, etc.;
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The first Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

Countries

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China

Other Identifiers

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QL1012-002

Identifier Type: -

Identifier Source: org_study_id