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Female InfertilityPhase 3REFRESHNCT05266924

Recombinant Follicle-stimulating Hormone in Treatment for Infertility

A Phase 3 study testing Recombinant Human Follicle Stimulating Hormone 900 IU (66.0 μg) / 1.5mL Solution for Injection in Prefilled Pen in people with Female Infertility, run by Bharat Serums and Vaccines Limited at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a randomized multi-centre, assessor-blind, parallel-group study to be conducted in 250 women in the age group of 20 to 39 years (both inclusive), who are indicated to undergo COS as part of assisted reproductive technology (ART). Read more about this study

Who is it for?
Ages 20 to 39 years, women only
Conditions the study is for
Female Infertility
What is being tested?
Recombinant Human Follicle Stimulating Hormone 900 IU (66.0 μg) / 1.5mL Solution for Injection in Prefilled Pen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteIndia
Study dates
23 Jul 2022to 30 Nov 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 39 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Subject has indication ART using COS.
  • Subject has regular menstrual cycle of 21-35 days.
  • Subject has one of the following:
  • FSH level <10 IU/L and Estradiol levl <80 pg/mL at day 2 or 3
  • Anti-mullerian hormone (AMH) level between 1 to 3.5 ng/mL during the menstrual cycle
  • Subject has an antral follicle count (AFC) of 10- 25, follicle ≤10 mm in diameter before ovarian stimulation
Show all 29Show fewer
  • Subject has a BMI ≥18 and <30 kg/m2
  • Subject has results of clinical laboratory tests within normal reference range
  • Subject and her partner are willing to provide written informed consent and comply
  • Exclusion Criteria Details Subject has history of >2 failed ART cycles
  • Subject with history of any endocrine abnormality, with documented hormone levels outside the reference range, which are clinically relevant, at screening
  • Subject with a history of ovarian hyper-response (i.e., previous COS cycle with >25 follicles of ≥11 mm in diameter on USG) or OHSS
  • Subject with documented polycystic ovarian syndrome (PCOS) at the time of screening
  • Subject with only one ovary or ovarian abnormality (including endometrioma >10 mm; visible on USG), at screening
  • Subject with documented severe endometriosis (American Society of Reproductive Medicine stage 3 or stage 4) or hydrosalpinx, at screening
  • Subject with submucosal fibroids ≥5 cm or any other clinically relevant pathology, which could impair embryo implantation or pregnancy continuation, at screening
  • Subject with a history of extrauterine pregnancy within 3 months of screening
  • Subject with history of poor response to gonadotropin treatment (retrieval of <4 oocytes) in the previous ART cycle
  • Subject with history of ≥3 miscarriages, at any time prior to screening
  • Subject who has tested positive for Human Immunodeficiency Virus, Hepatitis B or Hepatitis C at screening
  • Subject known to be allergic, hypersensitive, or intolerant to any of the preparations of r hFSH or its excipients, that will be used in the study
  • Subject with contraindications to the use of gonadotropins (e.g., tumours, undiagnosed vaginal bleeding, or ovarian cysts) or gonadotropin-releasing hormone (GnRH) antagonists
  • Subject with a history of epilepsy, thrombophilia, cardiovascular, gastrointestinal, hepatic, renal, pulmonary, auto-immune disease, or any active infection, requiring treatment which at the investigator's discretion might interfere with the study
  • Subject with history of malignancy
  • Subject who smokes or has stopped smoking within the last 3 months prior to screening
  • Subject with history of alcohol or drug abuse within 12 months prior to screening
  • Subject who has received any treatment listed below within 5 half-lives prior to screening:
  • Any agent(s) known to affect ovulation (e.g., neuroleptics);
  • Drugs known or suspected to be teratogenic in nature.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

India1 site

  • Om Research Center Om Surgical Center and Maternity Home

    Varanasi, Uttar Pradesh, 221007

Other trials in India

About this study

Official title: A Randomized, Parallel-group, Multi-Center, Assessor-blind Phase 3 Study to Compare the Efficacy, Safety and Ease of Use of Two Follicle Stimulating Hormone -Human Recombinant (r-hFSH) 900 IU (66.0 μg) / 1.5mL Solution for Injection in Prefilled Pen (Foligraf®- Manufactured by BSV and Gonal-f® Manufactured by Merck Serono) in Subjects Undergoing Controlled Ovarian Stimulation for Assisted Reproductive Technology

This is a randomized multi-centre, assessor-blind, parallel-group study to be conducted in 250 women in the age group of 20 to 39 years (both inclusive), who are indicated to undergo COS as part of assisted reproductive technology (ART). The participant will receive r-hFSH, fixed-dose for 5 days, and day 6 onwards the dose may be adjusted for a single cycle of COS followed by ART procedures, and post-ART follow-up for ongoing pregnancy.

The primary and secondary outcomes will be captured on days as per protocol. Adverse events will be noted for safety evaluation.

Being tested
Recombinant Human Follicle Stimulating Hormone 900 IU (66.0 μg) / 1.5mL Solution for Injection in Prefilled Pen
Medical subject headings
Infertility, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant Human Follicle Stimulating Hormone 900 IU (66.0 μg) / 1.5mL Solution for Injection in Prefilled PenDrug

    Also called Foligraf, Gonal-f

    fixed-dose of 225 IU/day, subcutaneous (SC), daily, for 5 days. further dosage will be adjusted till adequate follicular development.

Study groups in NCT05266924
Study groupRoleWhat they receive
Test groupExperimentalFoligraf 900 IU (66.0 μg) / 1.5mL Solution for Injection in Prefilled Pen Follicle Stimulating Hormone (Human Recombinant) manufactured by Bharat Serums and Vaccines Ltd
Receives: Drug: Recombinant Human Follicle Stimulating Hormone 900 IU (66.0 μg) / 1.5mL Solution for Injection in Prefilled Pen
Reference groupActive comparatorGonal-f Recombinant Human Follicle Stimulating Hormone
Receives: Drug: Recombinant Human Follicle Stimulating Hormone 900 IU (66.0 μg) / 1.5mL Solution for Injection in Prefilled Pen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of oocytes retrieved

    Number of oocytes retrieved

    Measured: Oocyte pick up - up to ~ 34 to 36 hours after human chorionic gonadotropin (hCG) administration

Secondary outcomes (17)

  1. Clinical pregnancy rate

    Clinical pregnancy rate

    Measured: 4 weeks after embryo transfer (ET)

  2. Ongoing Pregnancy rate

    Ongoing pregnancy rate

    Measured: 11±1 weeks after ET

  3. Cycle cancellation rate

    Cycle cancellation rate

    Measured: at Stimulation phase up to 20 days, oocyte pick up up to ~ 34 to 36 hours after hCG administration, ET anytime up to 8 weeks

  4. Total Doseof r-hFSH

    Total dose of r-hFSH (in IU) required for ovarian stimulation;

    Measured: at end of stimulation up to 20 days

  5. Number of Days of r-hFSH stimulation

    Number of days of r-hFSH stimulation

    Measured: at end of stimulation up to 20 days

  6. Number of subject Change in Dosage

    Proportion of subjects requiring change in dose

    Measured: post Day 6 till end of stimulation up to 20 days

  7. Hormonal Investigation

    Estradiol, Luteinizing, Progesterone, and inhibin b levels

    Measured: Day 6

  8. Follicle size on Day 6

    Number of follicles with size <11mm, Number of follicles with size 11- 14 mm, Number of follicles with size15 mm, Number of follicles with size16 mm, Number of follicles with size17 mm and Number of follicles with size ≥18 mm

    Measured: Day 6

  9. Follicle size at HCG administration

    Number of follicles with size <11mm, Number of follicles with size 11- 14 mm, Number of follicles with size15 mm, Number of follicles with size16 mm, Number of follicles with size17 mm and Number of follicles with size ≥18 mm mm)

    Measured: Day of hCG administration anytime upto 3 weeks

  10. Endometrium thickness

    Endometrial thickness (mm)

    Measured: day 6

  11. Endometrium at HCG administration

    Endometrial thickness (mm)

    Measured: day of hCG injection (anytime upto 3 weeks)

  12. Number of Matured oocytes

    Proportion of matured oocytes

    Measured: Oocyte pick up ~ 34 to 36 hours after hCG administration

  13. Number of good quality embryos

    Number of good quality embryos

    Measured: ET day (up to 8 weeks)

  14. Number of Adverse events

    Number of treatment-emergent adverse events (TEAE) reported

    Measured: Baseline, 1st day of stimulation, day 6 , end of stimulation up to 20 days, hCG administration, oocyte pick up ~ 34 to 36 hours after hCG administration, ET up to 8 weeks, clinical pregnancy (after 4 weeks of ET), ~12 weeks after ET

  15. Specific adverse events

    The number of patients with ovarian hyperstimulation syndrome (OHSS) reported

    Measured: Day 1 of Stimulation till ~12 weeks after ET

  16. Exploratory

    Ease of use of Pen - comparison of total score of Questionnaire to user of rhFSH pen

    Measured: End of stimulation up to 20 days

  17. Evaluation of immunogenicity (antibody) of r-hFSH

    Evaluation of immunogenicity of r-hFSH, comparison of antibody titre against r-hFSH in both groups

    Measured: Baseline, 4 weeks and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2022
  2. Study start23 Jul 2022
  3. Primary completion31 Aug 2023 (estimated)
  4. Study completion30 Nov 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a Randomized, Parallel-group, Multi-Center, Assessor-blind Phase 3 Study.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05266924
Sponsor's protocol ID
BSV_rhFSH_20_09
Acronym
REFRESH
Status last verified
Jul 2023
First submitted
23 Jan 2022
Last updated
1 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Recombinant Human Follicle Stimulating Hormone 900 IU (66.0 μg) / 1.5mL Solution for Injection in Prefilled Pen in people with Female Infertility, run by Bharat Serums and Vaccines Limited at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of oocytes retrieved (time frame: Oocyte pick up - up to ~ 34 to 36 hours after human chorionic gonadotropin (hCG) administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05266924.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.

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