Infertility, FemaleNCT06015698
Laparoscopic Tubal Disconnection Versus Laparoscopic Salpingectomy in Infertile Patients
A study testing Laparoscopic tubal disconnection and Laparoscopic salpingectomy in people with Infertility, Female, run by Ain Shams Maternity Hospital.
Trial summary
Tubal factor infertility is known to be one of the most common indications for IVF treatment. Patients with hydrosalpinges have been identified to have poor pregnancy outcomes such as lower implantation and pregnancy rates \& higher rates of spontaneous abortion and ectopic pregnancies. Read more about this study
- Who is it for?
- Ages 30 to 40 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Laparoscopic tubal disconnection and Laparoscopic salpingectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2023to 30 Aug 2024
- 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 30 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertile ( primary or secondary ).
- Age > 30 years .
- HSG with unilateral or bilateral hydrosaalpinx , confirmed laparoscopically.
- Scheduled for IVF/ICSI
Who cannot join
- Contraindications for laparoscopy
- Cardiac disease.
- BMI > 40 kg/m²
- Previous midline incision .
- Past history of TB peritonitis .
- Proximal tubal block by HCG .
Show all 11Show fewer
- Frozen pelvis proved by previous laparoscopy or laparotomy .
- Allergy to contrast media of HSG .
- Premature ovarian failure (Serum FSH >40 mIU/ml )
- Prescence of Male factor contributing to the infertility proved by abnormal semen analysis
- Prescence of Ovarian factor contributing to the infertility proved by the prescence of features suggesting anovulation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Laparoscopic Tubal Disconnection Versus Laparoscopic Salpingectomy in Infertile Patients Scheduled for IVF/ICSI. Randomized Controlled Trial
Tubal factor infertility is known to be one of the most common indications for IVF treatment. Patients with hydrosalpinges have been identified to have poor pregnancy outcomes such as lower implantation and pregnancy rates \& higher rates of spontaneous abortion and ectopic pregnancies. Surgical intervention can be recommended for patients with hydrosalpinx prior to IVF/ICSI.
This study will be done at Ain Shams University Maternity Hospital, to compare laparoscopic salpingectomy \& laparoscopic tubal disconnection as two surgical modalities of treatment of unilateral or bilateral hydrosalpinges in women older than 30 years and scheduled for IVF/ICSI, regarding implantation rates, clinical pregnancy rates, ongoing pregnancy rates, ectopic pregnancy rates, and operative complications.
Read the detailed description
It is estimated that tubal factors account for 14% of the causes of subfertility in women. The prevalence of hydrosalpinx among tubal diseases is as high as 30% of couples presenting with infertility from tubal factors.
Hydrosalpinx is the dilation of the fallopian tube in the presence of distal tubal occlusion, which may result from several causes. The leading cause of distal tubal occlusion is pelvic inflammatory disease (PID), usually resulting from a prior sexually transmitted disease, such as Chlamydia trachomatis or Neisseria gonorrhoeae. Tubal tuberculosis is an uncommon cause of hydrosalpinx, though re-emerging in developed countries. Other etiologies include endometriosis, appendicitis, and abdominopelvic surgery.
Depending on several patient factors, tubal microsurgery, or more commonly IVF with its improving success rates, are the recommended treatment options for tubal factor infertility.
In addition to its essential role in infertility, hydrosalpinx has an adverse effect on the outcome of in vitro fertilization (IVF) Hydrosalpinx can decrease the clinical pregnancy rate of IVF-ET, and increase the incidence of abortion and ectopic pregnancy.
The presence of hydrosalpinx has a negative effect on IVF/ET because of the suspected embryotoxicity of the hydrosalpingeal fluid due to a combination of mechanical and chemical factors thought to disrupt the endometrial environment.
Surgical treatment should be considered for all women with hydrosalpinges prior to IVF treatment (Johnson et al .,2004 )
Removing (salpingectomy) or occluding blocked or diseased fallopian tubes before IVF can increase pregnancy and live birth rates for women on the IVF program.
A network meta-analysis showed that Proximal tubal occlusion, salpingectomy, and aspiration for treatment of hydrosalpinx scored consistently better than did no intervention for the outcome of IVF/ET. Tubal occlusion and salpingectomy also improve ongoing pregnancy rates. Proximal tubal occlusion ranks highest for most of the outcomes assessed, whereas no intervention scores consistently as the least effective strategy for all outcomes
- Conditions
- Infertility, Female
- Being tested
- Laparoscopic tubal disconnection, Laparoscopic salpingectomy
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic tubal disconnectionProcedure or surgery
- The tube is grasped in the isthmic portion of the tube at least 2cm from the cornua. Bipolar coagulation will provide a more localized area of tubal burn so requiring at least 3cm of the tube to be coagulated
- The electrosurgical generator should set to deliver a power of 25W in nonmodulated mode to desiccate tissue sufficiently
- The tube should be coagulated with 2 to 3 contiguous burns to provide an area of about 3cm of coagulation. Th endpoint of coagulation is cessation of the current flow
- Then, the tube is severed in the middle of the burn area with laparoscopic scissors
- Ensure adequate hemostasis
Laparoscopic salpingectomyProcedure or surgery
- The tube will be removed from its anatomical attachements by progressive bipolar coagulation
- Progressive coagulation and cutting of the mesosalpinx begins at the proximal isthmus of the tube and progresses to the fimbriated end using bipolar coagulation and laparoscopic scissors
- Removal of the tube through one of the ancillary ports using artery forceps
- Ensure adequate hemostasis
| Study group | Role | What they receive |
|---|---|---|
| Tubal disconnection | Experimental | 1. The tube is grasped in the isthmic portion of the tube at least 2cm from the cornua. Bipolar coagulation will provide a more localized area of tubal burn so requiring at least 3cm of the tube to be coagulated
2. The electrosurgical generator should set to deliver a power of 25W in nonmodulated mode to desiccate tissue sufficiently
3. The tube should be coagulated with 2 to 3 contiguous burns to provide an area of about 3cm of coagulation. Th endpoint of coagulation is cessation of the current flow
4. Then, the tube is severed in the middle of the burn area with laparoscopic scissors
5. Ensure adequate hemostasis Receives: Procedure: Laparoscopic tubal disconnection |
| Salpingectomy | Active comparator | 1. The tube will be removed from its anatomical attachements by progressive bipolar coagulation
2. Progressive coagulation and cutting of the mesosalpinx begins at the proximal isthmus of the tube and progresses to the fimbriated end using bipolar coagulation and laparoscopic scissors
3. Removal of the tube through one of the ancillary ports using artery forceps
4. Ensure adequate hemostasis Receives: Procedure: Laparoscopic salpingectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Pregnancy with detectable heart beat 10weeks gestation or beyond
Measured: From 10 + 0 weeks of gestation
Secondary outcomes (3)
Operative time
in minutes starting from laparoscopic entry into the peritoneal cavity till removal of the primary trocar from the cavity
Measured: in minutes starting from laparoscopic entry into the peritoneal cavity till removal of the primary trocar from the cavity
Intraoperative complications
Bowel injury - Vascular injury
Measured: During the procedure
Postoperative complications
ileus - surgical emphysema
Measured: First 48 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start30 Aug 2023 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Elmaraghy, Ain Shams Maternity Hospital
- Investigators
- Hamdy B Alqenawy, M.D.,, Study director, Ain Shams university - Faculty of MedicineAhmed G Abd Elrahim, M.D.,, Principal investigator, Ain Shams university - Faculty of MedicineAlaa S Elsewafy, M.D.,, Principal investigator, Ain Shams university - Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015698
- Sponsor's protocol ID
- 10
- Status last verified
- Aug 2023
- First submitted
- 23 Aug 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ajonuma LC, Ng EH, Chan HC. New insights into the mechanisms underlying hydrosalpinx fluid formation and its adverse effect on IVF outcome. Hum Reprod Update. 2002 May-Jun;8(3):255-64. doi: 10.1093/humupd/8.3.255.
PubMed 12078836D'Arpe S, Franceschetti S, Caccetta J, Pietrangeli D, Muzii L, Panici PB. Management of hydrosalpinx before IVF: a literature review. J Obstet Gynaecol. 2015;35(6):547-50. doi: 10.3109/01443615.2014.985768. Epub 2014 Dec 1.
PubMed 25436898Dreyer K, Lier MC, Emanuel MH, Twisk JW, Mol BW, Schats R, Hompes PG, Mijatovic V. Hysteroscopic proximal tubal occlusion versus laparoscopic salpingectomy as a treatment for hydrosalpinges prior to IVF or ICSI: an RCT. Hum Reprod. 2016 Sep;31(9):2005-16. doi: 10.1093/humrep/dew050. Epub 2016 May 21.
PubMed 27209341Dun EC, Nezhat CH. Tubal factor infertility: diagnosis and management in the era of assisted reproductive technology. Obstet Gynecol Clin North Am. 2012 Dec;39(4):551-66. doi: 10.1016/j.ogc.2012.09.006.
PubMed 23182560Hong X, Ding WB, Yuan RF, Ding JY, Jin J. Effect of interventional embolization treatment for hydrosalpinx on the outcome of in vitro fertilization and embryo transfer. Medicine (Baltimore). 2018 Nov;97(48):e13143. doi: 10.1097/MD.0000000000013143.
PubMed 30508891Johnson N, van Voorst S, Sowter MC, Strandell A, Mol BW. Surgical treatment for tubal disease in women due to undergo in vitro fertilisation. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD002125. doi: 10.1002/14651858.CD002125.pub3.
PubMed 20091531Nackley AC, Muasher SJ. The significance of hydrosalpinx in in vitro fertilization. Fertil Steril. 1998 Mar;69(3):373-84. doi: 10.1016/s0015-0282(97)00484-6.
PubMed 9531862National Collaborating Centre for Women's and Children's Health (UK). Fertility: Assessment and Treatment for People with Fertility Problems. London: Royal College of Obstetricians & Gynaecologists; 2013 Feb. Available from http://www.ncbi.nlm.nih.gov/books/NBK247932/
PubMed 25340218Ng KYB, Cheong Y. Hydrosalpinx - Salpingostomy, salpingectomy or tubal occlusion. Best Pract Res Clin Obstet Gynaecol. 2019 Aug;59:41-47. doi: 10.1016/j.bpobgyn.2019.01.011. Epub 2019 Jan 29.
PubMed 30824209Strandell A. The influence of hydrosalpinx on IVF and embryo transfer: a review. Hum Reprod Update. 2000 Jul-Aug;6(4):387-95. doi: 10.1093/humupd/6.4.387.
PubMed 10972525Tsiami A, Chaimani A, Mavridis D, Siskou M, Assimakopoulos E, Sotiriadis A. Surgical treatment for hydrosalpinx prior to in-vitro fertilization embryo transfer: a network meta-analysis. Ultrasound Obstet Gynecol. 2016 Oct;48(4):434-445. doi: 10.1002/uog.15900. Epub 2016 Sep 13.
PubMed 26922863
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Tubal Disconnection Versus Laparoscopic Salpingectomy in Infertile Patients Scheduled for IVF/ICSI. Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06015698
- Acronym / sponsor ID
- 10
- Conditions
- Infertility, Female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 30 Aug 2023 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 29 Aug 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.
Tubal factor infertility is known to be one of the most common indications for IVF treatment. Patients with hydrosalpinges have been identified to have poor pregnancy outcomes such as lower implantation and pregnancy rates \& higher rates of spontaneous abortion and ectopic pregnancies. Surgical intervention can be recommended for patients with hydrosalpinx prior to IVF/ICSI.
This study will be done at Ain Shams University Maternity Hospital, to compare laparoscopic salpingectomy \& laparoscopic tubal disconnection as two surgical modalities of treatment of unilateral or bilateral hydrosalpinges in women older than 30 years and scheduled for IVF/ICSI, regarding implantation rates, clinical pregnancy rates, ongoing pregnancy rates, ectopic pregnancy rates, and operative complications.
Detailed description
It is estimated that tubal factors account for 14% of the causes of subfertility in women. The prevalence of hydrosalpinx among tubal diseases is as high as 30% of couples presenting with infertility from tubal factors.
Hydrosalpinx is the dilation of the fallopian tube in the presence of distal tubal occlusion, which may result from several causes. The leading cause of distal tubal occlusion is pelvic inflammatory disease (PID), usually resulting from a prior sexually transmitted disease, such as Chlamydia trachomatis or Neisseria gonorrhoeae. Tubal tuberculosis is an uncommon cause of hydrosalpinx, though re-emerging in developed countries. Other etiologies include endometriosis, appendicitis, and abdominopelvic surgery.
Depending on several patient factors, tubal microsurgery, or more commonly IVF with its improving success rates, are the recommended treatment options for tubal factor infertility.
In addition to its essential role in infertility, hydrosalpinx has an adverse effect on the outcome of in vitro fertilization (IVF) Hydrosalpinx can decrease the clinical pregnancy rate of IVF-ET, and increase the incidence of abortion and ectopic pregnancy.
The presence of hydrosalpinx has a negative effect on IVF/ET because of the suspected embryotoxicity of the hydrosalpingeal fluid due to a combination of mechanical and chemical factors thought to disrupt the endometrial environment.
Surgical treatment should be considered for all women with hydrosalpinges prior to IVF treatment (Johnson et al .,2004 )
Removing (salpingectomy) or occluding blocked or diseased fallopian tubes before IVF can increase pregnancy and live birth rates for women on the IVF program.
A network meta-analysis showed that Proximal tubal occlusion, salpingectomy, and aspiration for treatment of hydrosalpinx scored consistently better than did no intervention for the outcome of IVF/ET. Tubal occlusion and salpingectomy also improve ongoing pregnancy rates. Proximal tubal occlusion ranks highest for most of the outcomes assessed, whereas no intervention scores consistently as the least effective strategy for all outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tubal disconnection | Experimental | Procedure: Laparoscopic tubal disconnection1. The tube is grasped in the isthmic portion of the tube at least 2cm from the cornua. Bipolar coagulation will provide a more localized area of tubal burn so requiring at least 3cm of the tube to be coagulated 2. The electrosurgical generator should set to deliver a power of 25W in nonmodulated mode to desiccate tissue sufficiently 3. The tube should be coagulated with 2 to 3 contiguous burns to provide an area of about 3cm of coagulation. Th endpoint of coagulation is cessation of the current flow 4. Then, the tube is severed in the middle of the burn area with laparoscopic scissors 5. Ensure adequate hemostasis |
| Salpingectomy | Active comparator | Procedure: Laparoscopic salpingectomy1. The tube will be removed from its anatomical attachements by progressive bipolar coagulation 2. Progressive coagulation and cutting of the mesosalpinx begins at the proximal isthmus of the tube and progresses to the fimbriated end using bipolar coagulation and laparoscopic scissors 3. Removal of the tube through one of the ancillary ports using artery forceps 4. Ensure adequate hemostasis |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Infertile ( primary or secondary ).
- Age > 30 years .
- HSG with unilateral or bilateral hydrosaalpinx , confirmed laparoscopically.
- Scheduled for IVF/ICSI
Key exclusion criteria (11 listed)
- Contraindications for laparoscopy
- Proximal tubal block by HCG .
- Frozen pelvis proved by previous laparoscopy or laparotomy .
- Allergy to contrast media of HSG .
- Premature ovarian failure (Serum FSH >40 mIU/ml )
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 |
|---|---|---|
| Laparoscopic tubal disconnection1. The tube is grasped in the isthmic portion of the tube at least 2cm from the cornua. Bipolar coagulation will provide a more localized area of tubal burn so requiring at least 3cm of the tube to be coagulated 2. The electrosurgical generator should set to deliver a power of 25W in nonmodulated mode to desiccate tissue sufficiently 3. The tube should be coagulated with 2 to 3 contiguous burns to provide an area of about 3cm of coagulation. Th endpoint of coagulation is cessation of the current flow 4. Then, the tube is severed in the middle of the burn area with laparoscopic scissors 5. Ensure adequate hemostasis | Procedure or surgery | Tubal disconnection |
| Laparoscopic salpingectomy1. The tube will be removed from its anatomical attachements by progressive bipolar coagulation 2. Progressive coagulation and cutting of the mesosalpinx begins at the proximal isthmus of the tube and progresses to the fimbriated end using bipolar coagulation and laparoscopic scissors 3. Removal of the tube through one of the ancillary ports using artery forceps 4. Ensure adequate hemostasis | Procedure or surgery | Salpingectomy |
Primary outcome
Ongoing pregnancy rate
Time frame: From 10 + 0 weeks of gestation
Pregnancy with detectable heart beat 10weeks gestation or beyond
3 secondary outcomes
Operative time
Time frame: in minutes starting from laparoscopic entry into the peritoneal cavity till removal of the primary trocar from the cavity
Intraoperative complications
Time frame: During the procedure
Postoperative complications
Time frame: First 48 hours after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Background: PubMed 12078836Ajonuma LC, Ng EH, Chan HC. New insights into the mechanisms underlying hydrosalpinx fluid formation and its adverse effect on IVF outcome. Hum Reprod Update. 2002 May-Jun;8(3):255-64. doi: 10.1093/humupd/8.3.255.
- Background: PubMed 25436898D'Arpe S, Franceschetti S, Caccetta J, Pietrangeli D, Muzii L, Panici PB. Management of hydrosalpinx before IVF: a literature review. J Obstet Gynaecol. 2015;35(6):547-50. doi: 10.3109/01443615.2014.985768. Epub 2014 Dec 1.
- Background: PubMed 27209341Dreyer K, Lier MC, Emanuel MH, Twisk JW, Mol BW, Schats R, Hompes PG, Mijatovic V. Hysteroscopic proximal tubal occlusion versus laparoscopic salpingectomy as a treatment for hydrosalpinges prior to IVF or ICSI: an RCT. Hum Reprod. 2016 Sep;31(9):2005-16. doi: 10.1093/humrep/dew050. Epub 2016 May 21.
- Background: PubMed 23182560Dun EC, Nezhat CH. Tubal factor infertility: diagnosis and management in the era of assisted reproductive technology. Obstet Gynecol Clin North Am. 2012 Dec;39(4):551-66. doi: 10.1016/j.ogc.2012.09.006.
- Background: PubMed 30508891Hong X, Ding WB, Yuan RF, Ding JY, Jin J. Effect of interventional embolization treatment for hydrosalpinx on the outcome of in vitro fertilization and embryo transfer. Medicine (Baltimore). 2018 Nov;97(48):e13143. doi: 10.1097/MD.0000000000013143.
- Background: PubMed 20091531Johnson N, van Voorst S, Sowter MC, Strandell A, Mol BW. Surgical treatment for tubal disease in women due to undergo in vitro fertilisation. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD002125. doi: 10.1002/14651858.CD002125.pub3.
- Background: PubMed 9531862Nackley AC, Muasher SJ. The significance of hydrosalpinx in in vitro fertilization. Fertil Steril. 1998 Mar;69(3):373-84. doi: 10.1016/s0015-0282(97)00484-6.
- Background: PubMed 25340218National Collaborating Centre for Women's and Children's Health (UK). Fertility: Assessment and Treatment for People with Fertility Problems. London: Royal College of Obstetricians & Gynaecologists; 2013 Feb. Available from http://www.ncbi.nlm.nih.gov/books/NBK247932/
- Background: PubMed 30824209Ng KYB, Cheong Y. Hydrosalpinx - Salpingostomy, salpingectomy or tubal occlusion. Best Pract Res Clin Obstet Gynaecol. 2019 Aug;59:41-47. doi: 10.1016/j.bpobgyn.2019.01.011. Epub 2019 Jan 29.
- Background: PubMed 10972525Strandell A. The influence of hydrosalpinx on IVF and embryo transfer: a review. Hum Reprod Update. 2000 Jul-Aug;6(4):387-95. doi: 10.1093/humupd/6.4.387.
- Background: PubMed 26922863Tsiami A, Chaimani A, Mavridis D, Siskou M, Assimakopoulos E, Sotiriadis A. Surgical treatment for hydrosalpinx prior to in-vitro fertilization embryo transfer: a network meta-analysis. Ultrasound Obstet Gynecol. 2016 Oct;48(4):434-445. doi: 10.1002/uog.15900. Epub 2016 Sep 13.
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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.
Hamdy B Alqenawy, M.D., study director
Ain Shams university - Faculty of Medicine
Ahmed G Abd Elrahim, M.D., principal investigator
Ain Shams university - Faculty of Medicine
Alaa S Elsewafy, M.D., principal investigator
Ain Shams university - Faculty of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic tubal disconnection and Laparoscopic salpingectomy in people with Infertility, Female, run by Ain Shams Maternity Hospital.
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 11 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 29 Aug 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?
Contact Ahmed M Elmaraghy, M.D., (01010370980, amam85@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate (time frame: From 10 + 0 weeks of gestation). 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 NCT06015698, which also lists 11 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 2023.