Infertility, FemaleNCT06165484
Laparoscopy in Failed IVF
A study testing laparoscopy and hysteroscopy in people with Infertility, Female, run by Assiut University.
Trial summary
Current in-vitro fertilization (IVF) consumers are enjoying better success rates than early seekers, but only about a quarter of IVF cycles result in a live birth and many patients remain infertile after multiple IVF attempts. Recurrent IVF failure is distressing to patients and challenging to clinicians. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- laparoscopy and hysteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Nov 2025
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. The patients ages ranged from 20 to 40 years. 2. menstrual cycles with a duration of 24 to 38 days and no ovulatory dysfunction. 3. normal findings of pelvic ultrasonography and HSG assessment, without visible lesions that could cause implantation failure, for example: endometrial polyps, submucosal myomas, uterine septum and intrauterine adhesions.
- 4. hormonal values were within the normal range. 5. Semen analyses were normal according to the World Health Organization (WHO) 2010 criteria.
- 6. no previous surgical treatment for endometriosis; no previous oophorectomy or salpingectomy.
- 7. Patients included in the study had failed to conceive after at least one cycles of IVF-ET when indicated.
Who cannot join
- 1. Couples with severe male factor infertility. 2. Premature ovarian failure. 3. Patients with a poor ovarian reserve and poor responders. 4. Contraindication to laparoscopy such as mechanical or large abdominal mass (> 24 weeks gestation size).
- 5. Contraindication to hysteroscopy such as recent or active pelvic inflammatory disease and active uterine bleeding.
About this study
Official title: Evaluation of Patients of Failed in Vitro Fertilization Cycle: Prospective Cohort Study
Current in-vitro fertilization (IVF) consumers are enjoying better success rates than early seekers, but only about a quarter of IVF cycles result in a live birth and many patients remain infertile after multiple IVF attempts. Recurrent IVF failure is distressing to patients and challenging to clinicians. Despite interventions have been proposed to improve IVF outcome after couples of failed cycles, only a few of which are evidence based.
Laparoscopy, as the gold standard for the evaluation of the pelvis, was used to be the routine procedure for many reproductive physicians. It provides information on endometriosis, tubal patency, and pelvic adhesions and a chance to fix these lesions concurrently.
Read the detailed description
Current in-vitro fertilization (IVF) consumers are enjoying better success rates than early seekers, but only about a quarter of IVF cycles result in a live birth and many patients remain infertile after multiple IVF attempts. Recurrent IVF failure is distressing to patients and challenging to clinicians. Despite interventions have been proposed to improve IVF outcome after couples of failed cycles, only a few of which are evidence based.
Laparoscopy, as the gold standard for the evaluation of the pelvis, was used to be the routine procedure for many reproductive physicians. It provides information on endometriosis, tubal patency, and pelvic adhesions and a chance to fix these lesions concurrently.
The role of laparoscopy, especially in women whose normal screening tests suggest that pelvic pathology seem to be unlikely. However, sometimes a "normal" pelvic imaging can be misleading, since HSG or ultrasonography cannot to rule out hydrosalpinx and endometriosis completely. Furthermore, it has been shown that HSG is insufficient for predicting tubal potency for some patients with risk of pelvic adhesions, with a sensitivity between 0.0% and83% and specificity between 50% and 90%. When initial IVF treatments fail, can we offer the couples to choose additional cycle of IVF instead of evaluation of the potential peritoneal factor? In cases of otherwise so called "Unexplained infertility", the investigation cannot be considered complete until laparoscopy has been performed.
- Conditions
- Infertility, Female
- Being tested
- laparoscopy and hysteroscopy
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopy and hysteroscopyProcedure or surgery
laparoscopy and hysteroscopy for patient with failed IVF
| Study group | Role | What they receive |
|---|---|---|
| patient with failed ivf cycle | Experimental | Not described Receives: Procedure: laparoscopy and hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improving the pregnancy outcome in patients with recurrent IVF failure.
To assess if the diagnosis and treatment of pelvic or uterine pathologies with laparoscopy and hysteroscopy is of role in improving the pregnancy outcome (live birth rate and ongoing pregnancy rate) in patients with recurrent IVF failure .
Measured: 1.5 YEARS
Secondary outcomes (1)
Abnormal laparoscopy findings and surgery-related complications
Measured: 1.5 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study startJan 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Saber Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165484
- Sponsor's protocol ID
- failed IVF
- Status last verified
- Dec 2023
- First submitted
- 20 Nov 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patients of Failed in Vitro Fertilization Cycle: Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06165484
- Acronym / sponsor ID
- failed IVF
- Conditions
- Infertility, Female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 11 Dec 2023 (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.
Current in-vitro fertilization (IVF) consumers are enjoying better success rates than early seekers, but only about a quarter of IVF cycles result in a live birth and many patients remain infertile after multiple IVF attempts. Recurrent IVF failure is distressing to patients and challenging to clinicians. Despite interventions have been proposed to improve IVF outcome after couples of failed cycles, only a few of which are evidence based.
Laparoscopy, as the gold standard for the evaluation of the pelvis, was used to be the routine procedure for many reproductive physicians. It provides information on endometriosis, tubal patency, and pelvic adhesions and a chance to fix these lesions concurrently.
Detailed description
Current in-vitro fertilization (IVF) consumers are enjoying better success rates than early seekers, but only about a quarter of IVF cycles result in a live birth and many patients remain infertile after multiple IVF attempts. Recurrent IVF failure is distressing to patients and challenging to clinicians. Despite interventions have been proposed to improve IVF outcome after couples of failed cycles, only a few of which are evidence based.
Laparoscopy, as the gold standard for the evaluation of the pelvis, was used to be the routine procedure for many reproductive physicians. It provides information on endometriosis, tubal patency, and pelvic adhesions and a chance to fix these lesions concurrently.
The role of laparoscopy, especially in women whose normal screening tests suggest that pelvic pathology seem to be unlikely. However, sometimes a "normal" pelvic imaging can be misleading, since HSG or ultrasonography cannot to rule out hydrosalpinx and endometriosis completely. Furthermore, it has been shown that HSG is insufficient for predicting tubal potency for some patients with risk of pelvic adhesions, with a sensitivity between 0.0% and83% and specificity between 50% and 90%. When initial IVF treatments fail, can we offer the couples to choose additional cycle of IVF instead of evaluation of the potential peritoneal factor? In cases of otherwise so called "Unexplained infertility", the investigation cannot be considered complete until laparoscopy has been performed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with failed ivf cycle | Experimental | Procedure: laparoscopy and hysteroscopy |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1. The patients ages ranged from 20 to 40 years. 2. menstrual cycles with a duration of 24 to 38 days and no ovulatory dysfunction. 3. normal findings of pelvic ultrasonography and HSG assessment, without visible lesions that could cause implantation failure, for example: endometrial polyps, submucosal myomas, uterine septum and intrauterine adhesions.
- 4. hormonal values were within the normal range. 5. Semen analyses were normal according to the World Health Organization (WHO) 2010 criteria.
- 6. no previous surgical treatment for endometriosis; no previous oophorectomy or salpingectomy.
- 7. Patients included in the study had failed to conceive after at least one cycles of IVF-ET when indicated.
Key exclusion criteria (2 listed)
- 1. Couples with severe male factor infertility. 2. Premature ovarian failure. 3. Patients with a poor ovarian reserve and poor responders. 4. Contraindication to laparoscopy such as mechanical or large abdominal mass (> 24 weeks gestation size).
- 5. Contraindication to hysteroscopy such as recent or active pelvic inflammatory disease and active uterine bleeding.
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 and hysteroscopylaparoscopy and hysteroscopy for patient with failed IVF | Procedure or surgery | patient with failed ivf cycle |
Primary outcome
Improving the pregnancy outcome in patients with recurrent IVF failure.
Time frame: 1.5 YEARS
To assess if the diagnosis and treatment of pelvic or uterine pathologies with laparoscopy and hysteroscopy is of role in improving the pregnancy outcome (live birth rate and ongoing pregnancy rate) in patients with recurrent IVF failure .
1 secondary outcome
Abnormal laparoscopy findings and surgery-related complications
Time frame: 1.5 YEARS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopy and hysteroscopy in people with Infertility, Female, run by Assiut University.
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 2 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 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Improving the pregnancy outcome in patients with recurrent IVF failure. (time frame: 1.5 YEARS). 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 27 Dec 2023.