Ovulation InductionPhase 3NCT06725004
Oxytocin Versus Human Chorionic Gonadotropin as Trigger in Ovulation Induction
A Phase 3 study testing Oxytocin and Human Chorionic Gonadotropin in people with Ovulation Induction and Polycystic Ovary Syndrome, run by Shakeela Ishrat at 1 site in Bangladesh.
Trial summary
The goal of this clinical trial is to learn if injection oxytocin can be used as trigger in ovulation induction cycles in infertile women with polycystic ovary syndrome. The main questions it aims to answer are: Does injection oxytocin have similar ovulation rate as injection human chorionic gonadotropin (hCG) when… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Ovulation Induction, Polycystic Ovary Syndrome
- What is being tested?
- Oxytocin and Human Chorionic Gonadotropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jan 2023to 30 Jun 2024
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertile women with polycystic ovary syndrome
- Age less than 40 years
- Had ovulation induction with letrozole, with at least one mature follicle detected on folliculometry
Who cannot join
- Male factor abnormality
- Bilateral tubal block
- Any pelvic pathology like pelvic inflammatory diseases
- Any uterine abnormality
- Ovarian cysts
- Any cardiovascular diseases or other systemic diseases
Show all 9Show fewer
- Hyperprolactinemia or thyroid dysfunction
- Any drugs that affect the functions of hypothalamus, pituitary gland, and gonads
- Any known hypersensitivity to oxytocin
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
Bangabandhu Sheikh Mujib Medical University
Dhaka, Dhaka Division, 1200
About this study
Official title: Oxytocin Versus Human Chorionic Gonadotropin as Trigger in Ovulation Induction Cycles: A Randomized Controlled Trial
The goal of this clinical trial is to learn if injection oxytocin can be used as trigger in ovulation induction cycles in infertile women with polycystic ovary syndrome. The main questions it aims to answer are:
- Does injection oxytocin have similar ovulation rate as injection human chorionic gonadotropin (hCG) when used as trigger?
- Does injection oxytocin have similar pregnancy rate as injection human chorionic gonadotropin (hCG) when used as trigger?
Read more
Researchers will compare injection oxytocin to injection hCG to see if injection oxytocin is as effective as injection hCG as trigger in ovulation induction cycles in infertile women with polycystic ovary syndrome.
Participants will
- Take injection oxytocin or injection hCG as trigger over three subsequent ovulation induction cycles
- Be checked for ovulation by follicular rupture in TVS after 36 hours or raised serum progesterone level on day 7 after trigger
- Be checked for pregnancy by urine pregnancy test kit after missed period
Read the detailed description
This is an open label randomized controlled trial. After baseline transvaginal sonography (TVS), all the participants will be given tablet letrozole 5 mg or more from day 2 to day 6 of their menstrual cycle. Then participants will be followed up by TVS for follicular maturation and endometrial thickness.When the size of mature follicle will be at least 18mm , then participants will be randomized into experimental group and comparator group. The participants in experimental group will receive inj. (injection) oxytocin 10 IU (Inj. Linda 10 unit, Nuvista Pharmaceuticals Limited) intramuscular as trigger and the participants in control group received Inj. hCG 5000 IU (Inj. hCG 5000 IU, Popular Pharmaceuticals Limited) intramuscular as trigger. Participants will be followed up 36 hours after injection by TVS for follicular rupture. On the 7th day following oxytocin or hCG injection, serum progesterone level will be measured by chemiluminescent immunoassay . Participants will be followed until the next cycle for conception. If conception does not occur, then the procedure will be repeated in next cycle for 3 cycles.
Random sequence generation will be done by computer generated random numbers after permuted block randomization. Allocation concealment will be done by serially numbered closed envelops. Each envelop will be labeled with a serial number and has a card inside noting the intervention drug. A sample size of 24 in each group will be calculated to detect a non-inferiority margin difference between the group proportions with 80.9% power and the level of significance 0.05. Considering 10% patients drop out, 30 participants will be recruited in each group.
- Conditions
- Ovulation Induction, Polycystic Ovary Syndrome
- Being tested
- Oxytocin, Human Chorionic Gonadotropin
- Keywords
- Ovulation induction, Polycystic Ovary Syndrome, Oxytocin, Human Chorionic Gonadotropin (HCG)
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Injection Oxytocin 10 mg intramuscular as trigger for ovulation induction
Human Chorionic GonadotropinDrug
Injection Human Chorionic Gonadotropin 5000 IU intramuscular as trigger for ovulation induction
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | Participants will receive injection oxytocin 10 mg intramuscular as trigger for ovulation induction Receives: Drug: Oxytocin |
| Human Chorionic Gonadotropin | Active comparator | Participants will receive injection Human Chorionic Gonadotropin 5000 IU intramuscular as trigger for ovulation induction Receives: Drug: Human Chorionic Gonadotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants having ovulation
Number of participants having ovulation defined by findings on TVS after 36 hours and/or serum progesterone level 7th day after triggering
Measured: 1 week
Secondary outcomes (1)
Number of participants having pregnancy
Number of participants having pregnancy determined by urinary pregnancy kit test after missed period.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovulation InductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shakeela Ishrat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shakeela Ishrat, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Shakeela Ishrat, FCPS,MS, Study director, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725004
- Sponsor's protocol ID
- 4221
- Status last verified
- May 2025
- First submitted
- 5 Dec 2024
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mehrotra S, Singh U, Gupta HP, Tandon I, Saxena P. A prospective double blind study comparing the effects of oxytocin and human chorionic gonadotrophin as trigger for ovulation. J Obstet Gynaecol. 2014 Jan;34(1):13-6. doi: 10.3109/01443615.2013.822479.
PubMed 24359041George K, Kamath MS, Nair R, Tharyan P. Ovulation triggers in anovulatory women undergoing ovulation induction. Cochrane Database Syst Rev. 2014 Jan 31;2014(1):CD006900. doi: 10.1002/14651858.CD006900.pub3.
PubMed 24482059
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxytocin Versus Human Chorionic Gonadotropin as Trigger in Ovulation Induction Cycles: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06725004
- Acronym / sponsor ID
- 4221
- Conditions
- Ovulation Induction, Polycystic Ovary Syndrome
- Keywords
- Ovulation induction, Polycystic Ovary Syndrome, Oxytocin, Human Chorionic Gonadotropin (HCG)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shakeela IshratUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if injection oxytocin can be used as trigger in ovulation induction cycles in infertile women with polycystic ovary syndrome. The main questions it aims to answer are:
- Does injection oxytocin have similar ovulation rate as injection human chorionic gonadotropin (hCG) when used as trigger?
- Does injection oxytocin have similar pregnancy rate as injection human chorionic gonadotropin (hCG) when used as trigger?
Researchers will compare injection oxytocin to injection hCG to see if injection oxytocin is as effective as injection hCG as trigger in ovulation induction cycles in infertile women with polycystic ovary syndrome.
Participants will
- Take injection oxytocin or injection hCG as trigger over three subsequent ovulation induction cycles
- Be checked for ovulation by follicular rupture in TVS after 36 hours or raised serum progesterone level on day 7 after trigger
- Be checked for pregnancy by urine pregnancy test kit after missed period
Detailed description
This is an open label randomized controlled trial. After baseline transvaginal sonography (TVS), all the participants will be given tablet letrozole 5 mg or more from day 2 to day 6 of their menstrual cycle. Then participants will be followed up by TVS for follicular maturation and endometrial thickness.When the size of mature follicle will be at least 18mm , then participants will be randomized into experimental group and comparator group. The participants in experimental group will receive inj. (injection) oxytocin 10 IU (Inj. Linda 10 unit, Nuvista Pharmaceuticals Limited) intramuscular as trigger and the participants in control group received Inj. hCG 5000 IU (Inj. hCG 5000 IU, Popular Pharmaceuticals Limited) intramuscular as trigger. Participants will be followed up 36 hours after injection by TVS for follicular rupture. On the 7th day following oxytocin or hCG injection, serum progesterone level will be measured by chemiluminescent immunoassay . Participants will be followed until the next cycle for conception. If conception does not occur, then the procedure will be repeated in next cycle for 3 cycles.
Random sequence generation will be done by computer generated random numbers after permuted block randomization. Allocation concealment will be done by serially numbered closed envelops. Each envelop will be labeled with a serial number and has a card inside noting the intervention drug. A sample size of 24 in each group will be calculated to detect a non-inferiority margin difference between the group proportions with 80.9% power and the level of significance 0.05. Considering 10% patients drop out, 30 participants will be recruited in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: OxytocinParticipants will receive injection oxytocin 10 mg intramuscular as trigger for ovulation induction |
| Human Chorionic Gonadotropin | Active comparator | Drug: Human Chorionic GonadotropinParticipants will receive injection Human Chorionic Gonadotropin 5000 IU intramuscular as trigger for ovulation induction |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Infertile women with polycystic ovary syndrome
- Age less than 40 years
- Had ovulation induction with letrozole, with at least one mature follicle detected on folliculometry
Key exclusion criteria (9 listed)
- Male factor abnormality
- Bilateral tubal block
- Any pelvic pathology like pelvic inflammatory diseases
- Any uterine abnormality
- Ovarian cysts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinInjection Oxytocin 10 mg intramuscular as trigger for ovulation induction | Drug | Oxytocin |
| Human Chorionic GonadotropinInjection Human Chorionic Gonadotropin 5000 IU intramuscular as trigger for ovulation induction | Drug | Human Chorionic Gonadotropin |
Primary outcome
Number of participants having ovulation
Time frame: 1 week
Number of participants having ovulation defined by findings on TVS after 36 hours and/or serum progesterone level 7th day after triggering
1 secondary outcome
Number of participants having pregnancy
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Background: PubMed 24359041Mehrotra S, Singh U, Gupta HP, Tandon I, Saxena P. A prospective double blind study comparing the effects of oxytocin and human chorionic gonadotrophin as trigger for ovulation. J Obstet Gynaecol. 2014 Jan;34(1):13-6. doi: 10.3109/01443615.2013.822479.
- Background: PubMed 24482059George K, Kamath MS, Nair R, Tharyan P. Ovulation triggers in anovulatory women undergoing ovulation induction. Cochrane Database Syst Rev. 2014 Jan 31;2014(1):CD006900. doi: 10.1002/14651858.CD006900.pub3.
- Individual participant dataSharing planned: No
Related trials for Ovulation Induction
Recruiting
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Not yet recruiting
Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist in Controlled Ovarian Stimulation for In Vitro Fertilization: A Randomized Controlled Non-Inferiority Trial With a Concurrent Comparator Cohort Undergoing Progestin-Primed Ovarian Stimulation (PPOS)
Infertility, Female, Ovulation Induction
RecruitingPhase 1
E.N.D.E.A.V.O.R.: An Exemestane Needed Dose Efficacy and Verification as an Ovulation Induction Regimen Study
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RecruitingPhase 4
Progesterone Supplementation After Letrozole-stimulated Insemination
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Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shakeela Ishrat, FCPS,MS study director
Bangladesh Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxytocin and Human Chorionic Gonadotropin in people with Ovulation Induction and Polycystic Ovary Syndrome, run by Shakeela Ishrat at 1 site in Bangladesh.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 29 Aug 2025. 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 Bangladesh. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 participants having ovulation (time frame: 1 week). 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 NCT06725004, which also lists 2 linked publications.
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 29 Aug 2025; AzTrials last refreshed its copy on 31 Oct 2026.