EndometriosisPhase 2NCT07509411
Anti-TNFα Therapy for Improving Pregnancy Rates in Endometriosis Patients With Failed ICSI
A Phase 2 study testing TNF-α Inhibitor and Frozen Blastocyst Transfer (FBT) in people with Endometriosis, run by Benha University at 1 site in Egypt.
Trial summary
This prospective study targets infertile women with endometriosis (EM) who have experienced a previously failed Intracytoplasmic Sperm Injection (ICSI) trial. Using the P-I-C-O framework, the study evaluates whether the administration of an anti-TNF-α therapy (Intervention) 4-5 days before a frozen blastocyst transfer… Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- TNF-α Inhibitor and Frozen Blastocyst Transfer (FBT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2025to 7 Aug 2026
- Phase
- Phase 2
- 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 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Endometriosis diagnosed during infertility workup.
- History of a previously failed ICSI trial.
- Presence of more than one frozen embryo at the D-5 blastocyst stage qualified as good quality (Grade AA6).
- Signed informed consent.
Who cannot join
- Polycystic Ovary Syndrome (PCOS).
- Inflammatory disorders other than endometriosis.
- Currently maintaining immune-modulating therapies for any other cause.
- Refusal to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-TNFα Therapy Before Frozen Blastocyst Transfer Might Improve the Clinical Pregnancy Rate for Endometriosis Infertile Women With a Previously Failed ICSI Procedure. A Preliminary Clinical Assessment
This prospective study targets infertile women with endometriosis (EM) who have experienced a previously failed Intracytoplasmic Sperm Injection (ICSI) trial. Using the P-I-C-O framework, the study evaluates whether the administration of an anti-TNF-α therapy (Intervention) 4-5 days before a frozen blastocyst transfer (FBT) improves reproductive outcomes compared to standard protocols (Comparison). The primary outcome is the clinical pregnancy rate, with secondary outcomes focusing on implantation, ongoing pregnancy, and neonatal health. The goal is to determine if mitigating pro-inflammatory cytokines like TNF-α can enhance endometrial receptivity in this specific high-risk population.
- Conditions
- Endometriosis
- Being tested
- TNF-α Inhibitor, Frozen Blastocyst Transfer (FBT)
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNF-α InhibitorDrug
Administered 4-5 days before the frozen blastocyst transfer. A second session is provided two weeks later only for those with a positive chemical pregnancy diagnosis.
Frozen Blastocyst Transfer (FBT)Procedure or surgery
Transfer of a D-5 blastocyst (Grade AA6) following a standardized endometrial preparation involving GnRH-agonist, estradiol valerate, and progesterone.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | 73 infertile women with endometriosis and a history of failed ICSI. Receives: Drug: TNF-α Inhibitor; Procedure: Frozen Blastocyst Transfer (FBT) |
| Control Group | Active comparator | 72 infertile women with endometriosis and a history of failed ICSI. Receives: Procedure: Frozen Blastocyst Transfer (FBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Success Rate of Treatment Regimens in Achieving Clinical Pregnancy
The proportion of patients who achieved a clinical pregnancy (confirmed by ultrasound visualization of a gestational sac with fetal heart activity) following frozen blastocyst transfer, reflecting the effectiveness of the administered anti- TNFα therapy.
Measured: 4-6 weeks post-transfer.
Secondary outcomes (1)
Success Rate of Treatment in Achieving Healthy Neonatal Outcomes.
A composite measure including live birth rate, birth weight, and absence of major neonatal complications/NICU admissions.
Measured: At the time of delivery (approximately 9 months post-transfer).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start15 Aug 2025
- Primary completion15 Dec 2025
- Study completion7 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Benha 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two distinct groups (arms) simultaneously. Each group follows a specific protocol throughout the study duration to allow for a direct head-to-head comparison of outcomes.
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Sakr, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509411
- Sponsor's protocol ID
- RC 3.8.2025
- Status last verified
- Aug 2026
- First submitted
- 29 Mar 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-TNFα Therapy Before Frozen Blastocyst Transfer Might Improve the Clinical Pregnancy Rate for Endometriosis Infertile Women With a Previously Failed ICSI Procedure. A Preliminary Clinical Assessment
- ClinicalTrials.gov ID
- NCT07509411
- Acronym / sponsor ID
- RC 3.8.2025
- Conditions
- Endometriosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 7 Aug 2026 (actual)
- First posted
- 3 Apr 2026 (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.
This prospective study targets infertile women with endometriosis (EM) who have experienced a previously failed Intracytoplasmic Sperm Injection (ICSI) trial. Using the P-I-C-O framework, the study evaluates whether the administration of an anti-TNF-α therapy (Intervention) 4-5 days before a frozen blastocyst transfer (FBT) improves reproductive outcomes compared to standard protocols (Comparison). The primary outcome is the clinical pregnancy rate, with secondary outcomes focusing on implantation, ongoing pregnancy, and neonatal health. The goal is to determine if mitigating pro-inflammatory cytokines like TNF-α can enhance endometrial receptivity in this specific high-risk population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two distinct groups (arms) simultaneously. Each group follows a specific protocol throughout the study duration to allow for a direct head-to-head comparison of outcomes.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Drug: TNF-α Inhibitor, Procedure: Frozen Blastocyst Transfer (FBT)73 infertile women with endometriosis and a history of failed ICSI. |
| Control Group | Active comparator | Procedure: Frozen Blastocyst Transfer (FBT)72 infertile women with endometriosis and a history of failed ICSI. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Endometriosis diagnosed during infertility workup.
- History of a previously failed ICSI trial.
- Presence of more than one frozen embryo at the D-5 blastocyst stage qualified as good quality (Grade AA6).
- Signed informed consent.
Key exclusion criteria (4 listed)
- Polycystic Ovary Syndrome (PCOS).
- Inflammatory disorders other than endometriosis.
- Currently maintaining immune-modulating therapies for any other cause.
- Refusal to participate.
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 |
|---|---|---|
| TNF-α InhibitorAdministered 4-5 days before the frozen blastocyst transfer. A second session is provided two weeks later only for those with a positive chemical pregnancy diagnosis. | Drug | Intervention Group |
| Frozen Blastocyst Transfer (FBT)Transfer of a D-5 blastocyst (Grade AA6) following a standardized endometrial preparation involving GnRH-agonist, estradiol valerate, and progesterone. | Procedure or surgery | Control Group, Intervention Group |
Primary outcome
The Success Rate of Treatment Regimens in Achieving Clinical Pregnancy
Time frame: 4-6 weeks post-transfer.
The proportion of patients who achieved a clinical pregnancy (confirmed by ultrasound visualization of a gestational sac with fetal heart activity) following frozen blastocyst transfer, reflecting the effectiveness of the administered anti- TNFα therapy.
1 secondary outcome
Success Rate of Treatment in Achieving Healthy Neonatal Outcomes.
Time frame: At the time of delivery (approximately 9 months post-transfer).
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 11 Aug 2026.
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TNF-α Inhibitor and Frozen Blastocyst Transfer (FBT) in people with Endometriosis, run by Benha University at 1 site in Egypt.
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 4 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 11 Aug 2026. 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 Egypt. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The Success Rate of Treatment Regimens in Achieving Clinical Pregnancy (time frame: 4-6 weeks post-transfer.). 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 11 Aug 2026.