CClinicalTrials.gg
Status unknownNCT03579550COH/IUIUpdated Mar 13, 2019

Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus

An interventional study of office hysteroscopic metroplasty intervention arm in Hysteroscopy, Pregnancy Rate and Abortion, sponsored by Bulent Haydardedeoglu. Status unknown at 1 site in Turkey. Open to female participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-13.

Sponsored by Bulent Haydardedeoglu · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Hysteroscopy
  • Pregnancy Rate
  • Abortion
  • Ectopic Pregnancy
  • Intrauterine Insemination

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Keywords

  • dysmorphic uterus, metroplasty, hysteroscopy
03

In context

Pregnancy, Ectopic

79 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.

This study's enrollment of 86 is below the median of 102 across 41 interventional studies indexed under Pregnancy, Ectopic.

Browse Pregnancy, Ectopic studies →

Lead sponsor

Bulent Haydardedeoglu is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

Unexplained infertile couples with;

  1. Dysmorpic uterus in hysterosalpingography
  2. Normal spermiogram
  1. Bilateral patent tubes in hysterosalpingography 3. Normal ovarian reserve (AMH >1.5 ng/dl and/or total bilateral antral follicle count >8)

Exclusion criteria

Exclusion Criteria:

  1. Women with history of pelvic surgery including endometriosis and/or tubal surgery
  2. women with endometrioma which was visualised/suspected on transvaginal ultrasonography
  3. Women with anovulation
  4. Women with diminished ovarian reserve (AMH \< 1.5 ng/dl and/or total bilateral antral follicle count \<8)
  5. Couples with abnormal spermiogram parameters (oligospermia, oligoasthenospermia, oligoasthenoteratozoospermia, azospermia)
  6. Women with alive children
  7. Obese women (BMI>30 kg/m2)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
86 participants (actual)

Study arms

  • Active comparator
    Intervention arm: Hysterocopy group

    Office hyteroscopic metroplasty will be performed. After oparetion 9 months spontaneous conception Intervention arm for hysteroscopy group

    Procedure: office hysteroscopic metroplasty intervention arm

  • No intervention
    Spontaneous cycles plus COH/IUI

    Six months spontaneous coitus cycles plus 3 cycles of Clomiphene citrate and intrauterine insemination (COH/IUI)

Interventions

  • Procedureoffice hysteroscopic metroplasty intervention arm

    One group will be performed hysteroscopic metroplasty Second group will be undertaken to six months spontaneous coitus and three cycles of COH/IUI

    Also known as: spontaneous coitus plus COH/IUI

06

What researchers measure

Primary outcomes

  1. clinical pregnancy rate (CPR)

    Intrauterine gestational sac with viable fetal heart rate

    Time frame: 9 months

Secondary outcomes

  1. abortion

    the loss of pregnancy

    Time frame: 10 weeks

  2. ectopic pregnancy rate

    gestation with out of uterine cavity

    Time frame: 10 weeks

07

Study locations

1 site
  • Bulent Haydardedeoglu
    Adana, 01120, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03579550
Lead sponsor
Bulent Haydardedeoglu
Responsible party
Bulent Haydardedeoglu (Associate Prof. M.D., Baskent University) — Sponsor-investigator
First posted
Jul 6, 2018
Start date
Jun 8, 2018
Primary completion
Dec 31, 2019 (estimated)
Completion
Dec 30, 2020 (estimated)
Last update
Mar 13, 2019

Study contacts

Bulent Haydardedeoglu, Assoc.Prof.
principal investigator · Baskent University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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