Recombinant Human Chorionic Gonadotropin in Infertility

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/09/005010
• Date of registration: 11-09-2014
• Prospective Registration: Yes
• Primary sponsor: Bharat Serums and Vaccines Ltd
• Public title: Recombinant Human Chorionic Gonadotropin in Infertility
• Scientific title: A Prospective, Multicenter, Randomized, Open, Clinical Trial to Compare Clinical Equivalence Of Two Brands of Recombinant Human Chorionic Gonadotropin For Inducing Final Follicular Maturation in Intrauterine Insemination Cycles
• Date of first enrolment: 14-11-2014
• Target sample size: 210
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=6803
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Dr Anita Pai
• Affiliation: Bharat Serums & Vaccines Ltd

• Name: Ms Naju Turakhia
• Affiliation: Bharat Serums & Vaccines Ltd

Key inclusion & exclusion criteria

Inclusion criteria: 1. Female subjects aged 20 to 37 years (both inclusive)

2. BMI between 18 and 30 kg/m2

3. Less than 3 previous completed cycles

4. Anovulatory infertility, grade I or II endometriosis , PCOS or unexplained factor

5. Normogonadotropic subjects with normal Day 2 hormonal profile ( FSH (2.5 to 10.2 mIU/ml), LH (1.9 to 12.5mIU/ml), E2 (18.9 to 246.7pg/ml) TSH (0.35 to 5.5µIU/ml) and Prolactin (2.8 to 29.2ng/ml)

6. Criteria for hCG administration fulfilled (at least 1 follicle and not more than 5 follicles with diameter of > 18mm with acceptable serum E2 concentration not more than 1800 pg/ml)

7. Hysterosalpingography or laparoscopy, within 3 years before randomization, documenting a uterus consistent with expected normal function (e.g. no clinically interfering uterine fibroids) and at least one patent tube.

8. Semen parameters compatible with IUI using husband/donor sperm and semen analysis documenting >10 million/ml sperm count.
Exclusion criteria: 1. Female subjects aged less than 20 yrs and more than 37 years

2. Premature ovarian failure

3. Subjects requiring more than 300 IU of HMG/FSH as starting dose in previous treatment cycles or a known poor responder

4. Subjects with hypogondatropic hypogonadism

5. Uncontrolled thyroid or adrenal dysfunction

6. Previous history of severe Ovarian Hyper Stimulation Syndrome (OHSS)

7. Ovarian cysts > 10 mm or enlargement not due to polycystic ovary syndrome

8. Bilateral tubal block

9. Abnormal gynaecological bleeding of unknown origin

10. More than 3 previous failed IUIs

11. Subjects affected by pathologies associated with any contraindication of being pregnant

12. Neoplasias

13. Use of concomitant medication that might interfere with study evaluations

14. Hypersensitivity to any trial product



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: N97- Female infertility Health Condition 2: null- Infertility

Intervention(s)

Intervention1: Recombinant Human Chorionic Gonadotropin: Single Dose of 250 microgram (6000 IU) Injection Administered Subcutaneous
Control Intervention1: Ovitrelle: Single dose of 250 microgram (6000 IU)Injection administered Subcutaneous

Primary Outcome(s)

1. Serum hCG levels will be noted 36 ± 4 hours after administration of the hCG injection

2. USG evidence of rupture of follicle.

Timepoint: 36 ± 4 hours

Secondary Outcome(s)

Pregnancy rateTimepoint: 4 weeks

Secondary ID(s)

BSV/r-hCG/10, Version - 3, 15 Feb 2013

Source(s) of Monetary Support

Bharat Serums and Vaccines Ltd.

Ethics review

Status: Approved
Approval date: 04/08/2014
Contact:

Sir Ganga Ram Hospital Ethics Committee

Status: Approved
Approval date: 30/09/2014
Contact:

Institutional Ethics Committee Lokmanya Tilak Municipal Medical College

Status: Approved
Approval date: 14/10/2014
Contact:

IKDRC-ITS Ethics Committee

Status: Approved
Approval date: 14/10/2014
Contact:

IPGME & R Research Oversight Committee

Status: Approved
Approval date: 28/10/2014
Contact:

Choithram Hospital & Research Centre Ethics Committee

Status: Approved
Approval date: 28/11/2014
Contact:

ILS Hospital Ethics Committee

Status: Approved
Approval date: 10/12/2014
Contact:

Institutional Ethics Review Board - Novaditya

Status: Approved
Approval date: 19/12/2014
Contact:

Institutional Ethics Committee, Deenanath Mangeshkar Hospital & Research Centre

Status: Approved
Approval date: 19/12/2014
Contact:

Institutional Ethics Committee, Kings Georges Medical College

Status: Approved
Approval date: 22/12/2014
Contact:

Scientific Research and Ethical Review Committee (SRERC), Dept. of Laboratory Medicine, Batra Hospital & Medical Research Centre

Status: Approved
Approval date: 20/05/2015
Contact:

Institutional Ethics Committee, Nowrosjee Wadia Maternity Hospital

Status: Not Approved
Approval date:
Contact:

Gur Teg Bahadur Hospital Ethics Comittee

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee, Apollo BGS Hospitals

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee, Apollo Hospital, Bangalore

Status: Not Approved
Approval date:
Contact:

Institutional Ethics committee,Institute of Reproductive Medicine

Results

• Date Completed: 12/05/2016