HysteroscopyCOH/IUINCT03579550
Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus
A study testing office hysteroscopic metroplasty intervention arm in people with Hysteroscopy and Pregnancy Rate, run by Bulent Haydardedeoglu at 1 site in Turkey (Türkiye).
Trial summary
The correlation between dysmorphic uterus and infertility still remains enigmatic. We aim to evaluate the reproductive outcomes of metroplasty via office hysteroscopy in unexplained infertile women with dysmorphic uterus with comparing a group of unexplained infertile women performing 6 months spontaneous cycles plus… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hysteroscopy, Pregnancy Rate, Abortion
- What is being tested?
- office hysteroscopic metroplasty intervention arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jun 2018to 30 Dec 2020
- Phase
- Interventional
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Unexplained infertile couples with;
- Dysmorpic uterus in hysterosalpingography
- Normal spermiogram
- 2. Bilateral patent tubes in hysterosalpingography 3. Normal ovarian reserve (AMH >1.5 ng/dl and/or total bilateral antral follicle count >8)
Who cannot join
- Women with history of pelvic surgery including endometriosis and/or tubal surgery
- women with endometrioma which was visualised/suspected on transvaginal ultrasonography
- Women with anovulation
- Women with diminished ovarian reserve (AMH < 1.5 ng/dl and/or total bilateral antral follicle count <8)
- Couples with abnormal spermiogram parameters (oligospermia, oligoasthenospermia, oligoasthenoteratozoospermia, azospermia)
- Women with alive children
- Obese women (BMI>30 kg/m2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of Reproductive Outcomes of Hsyteroscopic Metroplasty Versus Spontaneous Coitus Plus COH/IUI Cycles in Unexplained Infertile Women With Dysmorphic Uterus
The correlation between dysmorphic uterus and infertility still remains enigmatic. We aim to evaluate the reproductive outcomes of metroplasty via office hysteroscopy in unexplained infertile women with dysmorphic uterus with comparing a group of unexplained infertile women performing 6 months spontaneous cycles plus 3 cycles controlled ovarian hyperstimulation and intrauterine insemination by randomized trial.
Read the detailed description
A dysmorphic uterus is a second-class (Class U1) uterine anomaly in the The European Society of Human Reproduction and Embryology (ESHRE) and the European Society for Gynaecological Endoscopy (ESGE) (ESHRE/ESGE) consensus on the classification of congenital genital tract anomalies, which was formerly known as "T-shaped uterus" in the American Fertility Society (AFS) Classification of Anomalies of the Müllerian Duct that leads to poor reproductive and obstetric outcomes.
The reproductive performance of dysmorphic uterus is not well-known issue. We designed a randomized trial in unexplained infertile couples women with dysmorphic uterus. After allocation of properly selected women, hysteroscopy group will be undertaken metroplasty procedure and 9 months follow-up period with natural conception. Second group will be undertaken to six months spontaneous coitus and three cycles clomiphene citrate and intrauterine insemination cycles. After nine months of follow-up of both groups, the pregnancy and reproductive outcomes will be evaluated.
- Being tested
- office hysteroscopic metroplasty intervention arm
- Keywords
- dysmorphic uterus, metroplasty, hysteroscopy
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
office hysteroscopic metroplasty intervention armProcedure or surgery
Also called spontaneous coitus plus COH/IUI
One group will be performed hysteroscopic metroplasty Second group will be undertaken to six months spontaneous coitus and three cycles of COH/IUI
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm: Hysterocopy group | Active comparator | Office hyteroscopic metroplasty will be performed. After oparetion 9 months spontaneous conception Intervention arm for hysteroscopy group Receives: Procedure: office hysteroscopic metroplasty intervention arm |
| Spontaneous cycles plus COH/IUI | No intervention | Six months spontaneous coitus cycles plus 3 cycles of Clomiphene citrate and intrauterine insemination (COH/IUI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate (CPR)
Intrauterine gestational sac with viable fetal heart rate
Measured: 9 months
Secondary outcomes (2)
abortion
the loss of pregnancy
Measured: 10 weeks
ectopic pregnancy rate
gestation with out of uterine cavity
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start8 Jun 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysteroscopyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomised trial
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulent Haydardedeoglu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bulent Haydardedeoglu, Baskent University
- Investigators
- Bulent Haydardedeoglu, Assoc.Prof., Principal investigator, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579550
- Sponsor's protocol ID
- KA17/151
- Acronym
- COH/IUI
- Status last verified
- Mar 2019
- First submitted
- 26 Jun 2018
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Reproductive Outcomes of Hsyteroscopic Metroplasty Versus Spontaneous Coitus Plus COH/IUI Cycles in Unexplained Infertile Women With Dysmorphic Uterus
- ClinicalTrials.gov ID
- NCT03579550
- Acronym / sponsor ID
- COH/IUI / KA17/151
- Keywords
- dysmorphic uterus, metroplasty, hysteroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Bulent HaydardedeogluUniversity, hospital or other
- Study start
- 8 Jun 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 6 Jul 2018 (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 correlation between dysmorphic uterus and infertility still remains enigmatic. We aim to evaluate the reproductive outcomes of metroplasty via office hysteroscopy in unexplained infertile women with dysmorphic uterus with comparing a group of unexplained infertile women performing 6 months spontaneous cycles plus 3 cycles controlled ovarian hyperstimulation and intrauterine insemination by randomized trial.
Detailed description
A dysmorphic uterus is a second-class (Class U1) uterine anomaly in the The European Society of Human Reproduction and Embryology (ESHRE) and the European Society for Gynaecological Endoscopy (ESGE) (ESHRE/ESGE) consensus on the classification of congenital genital tract anomalies, which was formerly known as "T-shaped uterus" in the American Fertility Society (AFS) Classification of Anomalies of the Müllerian Duct that leads to poor reproductive and obstetric outcomes.
The reproductive performance of dysmorphic uterus is not well-known issue. We designed a randomized trial in unexplained infertile couples women with dysmorphic uterus. After allocation of properly selected women, hysteroscopy group will be undertaken metroplasty procedure and 9 months follow-up period with natural conception. Second group will be undertaken to six months spontaneous coitus and three cycles clomiphene citrate and intrauterine insemination cycles. After nine months of follow-up of both groups, the pregnancy and reproductive outcomes will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective randomised trial
| Arm | Type | Receives |
|---|---|---|
| Intervention arm: Hysterocopy group | Active comparator | Procedure: office hysteroscopic metroplasty intervention armOffice hyteroscopic metroplasty will be performed. After oparetion 9 months spontaneous conception Intervention arm for hysteroscopy group |
| Spontaneous cycles plus COH/IUI | No intervention | –Six months spontaneous coitus cycles plus 3 cycles of Clomiphene citrate and intrauterine insemination (COH/IUI) |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Unexplained infertile couples with;
- Dysmorpic uterus in hysterosalpingography
- Normal spermiogram
- 2. Bilateral patent tubes in hysterosalpingography 3. Normal ovarian reserve (AMH >1.5 ng/dl and/or total bilateral antral follicle count >8)
Key exclusion criteria (7 listed)
- Women with history of pelvic surgery including endometriosis and/or tubal surgery
- women with endometrioma which was visualised/suspected on transvaginal ultrasonography
- Women with anovulation
- Women with diminished ovarian reserve (AMH < 1.5 ng/dl and/or total bilateral antral follicle count <8)
- Couples with abnormal spermiogram parameters (oligospermia, oligoasthenospermia, oligoasthenoteratozoospermia, azospermia)
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 |
|---|---|---|
| office hysteroscopic metroplasty intervention armAlso: spontaneous coitus plus COH/IUIOne group will be performed hysteroscopic metroplasty Second group will be undertaken to six months spontaneous coitus and three cycles of COH/IUI | Procedure or surgery | Intervention arm: Hysterocopy group |
Primary outcome
clinical pregnancy rate (CPR)
Time frame: 9 months
Intrauterine gestational sac with viable fetal heart rate
2 secondary outcomes
abortion
Time frame: 10 weeks
ectopic pregnancy rate
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
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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.
Bulent Haydardedeoglu, Assoc.Prof. principal investigator
Baskent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing office hysteroscopic metroplasty intervention arm in people with Hysteroscopy and Pregnancy Rate, run by Bulent Haydardedeoglu at 1 site in Turkey (Türkiye).
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 4 inclusion and 7 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 13 Mar 2019. 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 Turkey (Türkiye). 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.
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?
clinical pregnancy rate (CPR) (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2019.