Unexplained InfertilityNCT04465045
Unexplained Infertility Treated by Hysteroscopy-laparoscopy
An observational study of Unexplained Infertility, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Retrospective study, including patients from january 2013 to december 2018, who were diagnosed with unexplained infertility : spontaneously ovulating women with normal pelvic ultrasound scan, patent tubes on hysterosalpingography and normal pelvic exam or pelvic MRI normal. Read more about this study
- Who is it for?
- Ages 18 to 43 years
- Conditions the study is for
- Unexplained Infertility
- What is being tested?
- Laparoscopy-hysteroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2020to 1 Oct 2020
- Phase
- Observational
- 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 18 to 43 years
- All sexes
- No healthy volunteers
- Adult
Study population: In Montpellier University center only, France : from january 2013 to december 2018 unexplained infertile couple, trying to conceive for more than one year and operated by laparoscopy-hysteroscopy
Who may be able to join
- 18-43y
- unexplained infertility
- operated from laparoscopy-hysteroscopy at montpellier university hospital
Who cannot join
- an IMR that diagnoses formelly an endometriosis, or endometriosic ovarian cysts
- any non respect to inclusion criterias
- non respect of our definition of unexplained infertility (such as bilateral tubal issue on hysterosalpingograms)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unexplained Infertility Treated by Hysteroscopy-laparoscopy : Predictive Factors of Pregnancy
Retrospective study, including patients from january 2013 to december 2018, who were diagnosed with unexplained infertility : spontaneously ovulating women with normal pelvic ultrasound scan, patent tubes on hysterosalpingography and normal pelvic exam or pelvic MRI normal. Semen analyses were normal according to the World Health Organization criteria. Couples were referred for diagnostic laparoscopy and hysteroscopy. They were then addressed for spontaneous fertility or ART to conceive. The investigators would like to see how many surgeries were useful to assess a diagnostic, and if operating allows a satisfying pregnancy rate. The investigators would like to assess how many diagnosis was done after surgery and how many pregnancy were obtained. The investigators search other prognostic factors than age or parity.
- Conditions
- Unexplained Infertility
- Being tested
- Laparoscopy-hysteroscopy
- Keywords
- Ovulation, semen analysis, tubal patency, pelvic ultrasound scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopy-hysteroscopyProcedure or surgery
Under general anesthesia, we start by a first look in laparoscopy, to look for endometriosis mainly, tubal infertility, ovarian cysts or any abnormalities that may not have been suspected on the first exam. Then we check tubal patency after a look at the uterine cavity by hysteroscopy. Then we treat everything possible to treat to improve fertility, spontaneous or with ART.
| Study group | Role | What they receive |
|---|---|---|
| Unique cohort | All women, 18 to 43 years, operated from laparoscopy-hysteroscopy for unexplained infertility in montpellier university hospital Receives: Procedure: Laparoscopy-hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
pregnancy with an hearbeat on a pelvic ultrasound scan
Measured: 1 day
Secondary outcomes (6)
Number of Participants with miscarriage
Number of Participants with miscarriage : positive pregnancy blood test, resulting in bleeding
Measured: 1 day
live birth rate
live birth rate : birth of a viable foetus after 24 SA
Measured: 1 day
Number of Participants with fœtal losses
Number of Participants with Foetal losses : loss of a non viable foetus, before 24 SA
Measured: 1 day
Number of Participants with ectopic pregnancy
Number of Participants with ectopic pregnancy: tubal pregnancy highly suspected by blood test or seen on a pelvic ultrasound scan
Measured: 1 day
Number of Participants with surgical complications
Number of Participants withSurgical complications : during surgery, and a few days after surgery
Measured: 1 day
Number of Participants with type of surgery
Number of Participants with type of surgery: tubal surgeries, adhesiolysis, endometriosis surgeries, hysteroscopic gestures.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start1 Jun 2020
- Primary completion30 Sep 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unexplained InfertilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Vincens, doctor of medecine, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465045
- Sponsor's protocol ID
- RECHMPL20_0084
- Status last verified
- Dec 2020
- First submitted
- 6 Jul 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unexplained Infertility Treated by Hysteroscopy-laparoscopy : Predictive Factors of Pregnancy
- ClinicalTrials.gov ID
- NCT04465045
- Acronym / sponsor ID
- RECHMPL20_0084
- Conditions
- Unexplained Infertility
- Keywords
- Ovulation, semen analysis, tubal patency, pelvic ultrasound scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 9 Jul 2020 (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.
Retrospective study, including patients from january 2013 to december 2018, who were diagnosed with unexplained infertility : spontaneously ovulating women with normal pelvic ultrasound scan, patent tubes on hysterosalpingography and normal pelvic exam or pelvic MRI normal. Semen analyses were normal according to the World Health Organization criteria. Couples were referred for diagnostic laparoscopy and hysteroscopy. They were then addressed for spontaneous fertility or ART to conceive. The investigators would like to see how many surgeries were useful to assess a diagnostic, and if operating allows a satisfying pregnancy rate. The investigators would like to assess how many diagnosis was done after surgery and how many pregnancy were obtained. The investigators search other prognostic factors than age or parity.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unique cohort | – | Procedure: Laparoscopy-hysteroscopyAll women, 18 to 43 years, operated from laparoscopy-hysteroscopy for unexplained infertility in montpellier university hospital |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- In Montpellier University center only, France : from january 2013 to december 2018 unexplained infertile couple, trying to conceive for more than one year and operated by laparoscopy-hysteroscopy
Key inclusion criteria (3 listed)
- 18-43y
- unexplained infertility
- operated from laparoscopy-hysteroscopy at montpellier university hospital
Key exclusion criteria (3 listed)
- an IMR that diagnoses formelly an endometriosis, or endometriosic ovarian cysts
- any non respect to inclusion criterias
- non respect of our definition of unexplained infertility (such as bilateral tubal issue on hysterosalpingograms)
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 |
|---|---|---|
| Laparoscopy-hysteroscopyUnder general anesthesia, we start by a first look in laparoscopy, to look for endometriosis mainly, tubal infertility, ovarian cysts or any abnormalities that may not have been suspected on the first exam. Then we check tubal patency after a look at the uterine cavity by hysteroscopy. Then we treat everything possible to treat to improve fertility, spontaneous or with ART. | Procedure or surgery | Unique cohort |
Primary outcome
clinical pregnancy rate
Time frame: 1 day
pregnancy with an hearbeat on a pelvic ultrasound scan
6 secondary outcomes
Number of Participants with miscarriage
Time frame: 1 day
live birth rate
Time frame: 1 day
Number of Participants with fœtal losses
Time frame: 1 day
Number of Participants with ectopic pregnancy
Time frame: 1 day
Number of Participants with surgical complications
Time frame: 1 day
Number of Participants with type of surgery
Time frame: 1 day
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 Dec 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Claire Vincens, doctor of medecine study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unexplained Infertility, run by University Hospital, Montpellier at 1 site in France.
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 3 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 Dec 2020. 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 France. 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?
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?
clinical pregnancy rate (time frame: 1 day). 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 29 Dec 2020; AzTrials last refreshed its copy on 29 Oct 2026.