Unexplained InfertilityPhase 2NCT03792997
A Therapeutic Protocol in Previous Failed ART Patients With High Total NK Cells
A Phase 2 study testing combination therapy for high peripheral NK cells in people with Unexplained Infertility, run by Benha University at 1 site in Egypt.
Trial summary
patients with previous failed ART cycles with high peripheral NK cells will be divided into 2 groups: one group of patients with previous failed ART cyles will undergo standard treatment but the other group will have in addition lipid emulsion \&prednisolone \& LMWH Read more about this study
- Who is it for?
- Ages 20 to 37 years, women only
- Conditions the study is for
- Unexplained Infertility
- What is being tested?
- combination therapy for high peripheral NK cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 10 Dec 2021
- 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 20 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients with high peripheral NK cells > 10% unexplained infertility cases cases with endometriosis
Who cannot join
- uterine factors poor responders< 3 MII oocytes severe male factor \& Azospermia
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Banha University- Hawaa Fertility center
Banhā, Qalyubia Governorate, 13512
About this study
Official title: A Therapeutic Protocol in Previous Failed ART Patients With High Total NK Cells: A Randomized Controlled Trial
patients with previous failed ART cycles with high peripheral NK cells will be divided into 2 groups: one group of patients with previous failed ART cyles will undergo standard treatment but the other group will have in addition lipid emulsion \&prednisolone \& LMWH
Read the detailed description
patients with previous failed ART cycles with high peripheral NK cells will be divided into 2 groups: one group of patients with previous failed ART cyles will undergo standard treatment but the other group will have in addition lipid emulsion begin in the cycle before embryo transfer \&prednisolone begin with the start of lipid emulsion \& LMWH begin with the day of ET
- Conditions
- Unexplained Infertility
- Being tested
- combination therapy for high peripheral NK cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination therapy for high peripheral NK cellsCombination product
lipid emulsion \& prednisolone \& LMWH
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | regular treatment with embryo transfer in the form of progesterone I.M. \& Supp. in addition to low dose aspirin \& folic acid Receives: Combination Product: combination therapy for high peripheral NK cells |
| study | Experimental | regular treatment with embryo transfer in the form of progesterone I.M. \& Supp. in addition to low dose aspirin \& folic acid but the investigators add in this arm lipid emulsion \& prednisolone \& LMWH Receives: Combination Product: combination therapy for high peripheral NK cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
chemical pregnancy rate
quantitative serum test
Measured: 14 days
Secondary outcomes (1)
clinical pregnancy rate
gestational sac and fetal echo by ultrasound
Measured: 6 weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start1 Jan 2019
- Primary completion15 Dec 2019
- Study completion10 Dec 2021
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Collaborators
- Hawaa Fertility Center
- Responsible party
- Principal investigator, Ahmed Saad, Benha University
- Investigators
- ahmed sa saad, MD, ph D, Principal investigator, Hawaa Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792997
- Sponsor's protocol ID
- Hawaa-6
- Status last verified
- Dec 2021
- First submitted
- 2 Jan 2019
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol, statistical analysis \& results
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Therapeutic Protocol in Previous Failed ART Patients With High Total NK Cells: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03792997
- Acronym / sponsor ID
- Hawaa-6
- Conditions
- Unexplained Infertility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Collaborators
- Hawaa Fertility Center
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 4 Jan 2019 (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.
patients with previous failed ART cycles with high peripheral NK cells will be divided into 2 groups: one group of patients with previous failed ART cyles will undergo standard treatment but the other group will have in addition lipid emulsion \&prednisolone \& LMWH
Detailed description
patients with previous failed ART cycles with high peripheral NK cells will be divided into 2 groups: one group of patients with previous failed ART cyles will undergo standard treatment but the other group will have in addition lipid emulsion begin in the cycle before embryo transfer \&prednisolone begin with the start of lipid emulsion \& LMWH begin with the day of ET
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Combination Product: combination therapy for high peripheral NK cellsregular treatment with embryo transfer in the form of progesterone I.M. \& Supp. in addition to low dose aspirin \& folic acid |
| study | Experimental | Combination Product: combination therapy for high peripheral NK cellsregular treatment with embryo transfer in the form of progesterone I.M. \& Supp. in addition to low dose aspirin \& folic acid but the investigators add in this arm lipid emulsion \& prednisolone \& LMWH |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with high peripheral NK cells > 10% unexplained infertility cases cases with endometriosis
Key exclusion criteria (1 listed)
- uterine factors poor responders< 3 MII oocytes severe male factor \& Azospermia
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 |
|---|---|---|
| combination therapy for high peripheral NK cellslipid emulsion \& prednisolone \& LMWH | Combination product | control, study |
Primary outcome
chemical pregnancy rate
Time frame: 14 days
quantitative serum test
1 secondary outcome
clinical pregnancy rate
Time frame: 6 weeks of pregnancy
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 3 Jan 2022.
- Individual participant dataSharing planned: Yes. study protocol, statistical analysis \& results
Related trials for Unexplained Infertility
Recruiting
Sperm Preparation Prior to Intrauterine Insemination Study
Infertility, Infertility Secondary
Recruiting
Hormone-free Antral Retrieval for Viable Embryo Storage & Transfer
Infertility
Active, not recruitingPhase 3
FRIEND: Fibroids and Unexplained Infertility Treatment With Epigallocatechin Gallate; A Natural CompounD in Green Tea
Leiomyoma, Uterine
Recruiting
Royal Jelly Supplementation in Unexplained Male Infertility
Unexplained Infertility, Male Infertility
Not yet recruitingObservational study
ERA in Young Primary Infertile RIF Patients
Recurrent Implantation Failure
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.
ahmed sa saad, MD, ph D principal investigator
Hawaa Fertility Center
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 combination therapy for high peripheral NK cells in people with Unexplained Infertility, 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 1 inclusion and 1 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 3 Jan 2022. 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?
chemical pregnancy rate (time frame: 14 days). 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 3 Jan 2022.