InfertilityPhase 2/3NCT02468258
Multi-factorial Analysis of the Follicular Fluid Milieu to Explore the Discrepant Effect of Follicular Fluid Endometrial Flushing on Outcome of Assisted Reproduction Trial
A Phase 2/3 study testing endometrial flushing in people with Infertility, run by Benha University at 1 site in Egypt.
Trial summary
Patients \& Methods: Eighty infertile women were randomly categorized into: Group EF (n=40) had EF after oocyte retrieval and Control group (n=40) did not have EF. All women were subjecte to the standard down-regulation regimen followed by controlled ovarian hyper stimulation . Read more about this study
- Who is it for?
- Ages 19 to 37 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- endometrial flushing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2013to Jul 2017
- Phase
- Phase 2/3
- 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 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Inclusion criteria included age younger than 37 years, having a regular and proven ovulatory menstrual cycle with a length of 26-35 days and body mass index (BMI) of <35 kg/m2, and serum FSH and estradiol were within normal range. Indications for IVF were tubal pathology, unexplained infertility, and male factor
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Patients \& Methods: Eighty infertile women were randomly categorized into: Group EF (n=40) had EF after oocyte retrieval and Control group (n=40) did not have EF. All women were subjecte to the standard down-regulation regimen followed by controlled ovarian hyper stimulation . Oocytes were retrieved 34-36 h after hCG administration and aspirated FF was collected and centrifuged at 600 rpm for 10 min and 5-ml sample of supernatant was obtained for ELISA estimation of tumor necrosis factor-α (TNF-α), granulocyte colony-stimulating factor (G-CSF), leptin and anti-Mullerian Hormone (AMH) levels in both groups. The remaining amount was used for EF in EF group and was discarded in control group. Pregnancy was diagnosed by measurement of β-HCG level and confirmed by transvaginal sonography as clinical pregnancy
Read the detailed description
Patients were randomly, using sealed envelops, categorized into two groups. Group EF included 40 women subjected to FF endometrial flushing after oocyte retrieval and Control group included 40 women would not have FF endometrial flushing.
Controlled ovarian stimulation The protocol for controlled ovarian hyperstimulation preceded by the standard down-regulation regimen described by Chang et al., (11). Pituitary down-regulation was evaluated by a determination of serum estradiol (E2), LH concentration and transvaginal sonography of the ovaries. Serum E2 and LH was assayed using a commercially available competitive immunoassay with the Immulite Analyzer (DPC Coat-a Count; Diagnostic Products Corp., USA) at Unit laboratory. All patients received triptorelin acetate (Decapeptyl; Ferring, Germany) 0.1 mg injected subcutaneously once daily, beginning on day 21 of the previous cycle until the 1st day of the next cycle. If the serum E2 level was <35 pg/ml, LH <10 mIU/ml and no follicles >10 mm in diameter were noted on TVS, Decapeptyl was decreased to half a dose and continued until and including the day of hCG administration. If the pituitary was not suppressed, Decapeptyl was continued at the same dose and the serum E2, LH level was rechecked daily until suppression was achieved.
Patients received hMG (Menogon; Ferring Pharamceutical Co, Germany) in a dose of 225 IU/day after pituitary suppression. Gonadotrophin was administered daily for 6 days, after which the dose was individualized according to ovarian follicular growth. Patients were monitored every other day starting on day 6 of stimulation with TVS and serum E2. Intramuscular hCG (Pregnyl; Organon, Holland) 10,000 IU was administered when at least 5 follicles were ≥18 mm in diameter and with adequate serum E2 levels. Progesterone was measured only on the day of hCG administration. Patients were divided into low, moderate and high responders, according to the total dose of hMG used up to the day of hCG injection (12).
Oocytes were retrieved 34-36 h after hCG administration and aspirated FF was collected in a sterile container and was centrifuged at 600 rpm for 10 min at room temperature and a 5-ml sample of the supernatant was obtained for laboratory workup, while the remaining amount of supernatant was used to flush the endometrium through an applied uterine catheter in FF group and was discarded in the other group.
Oocyte preparation For ICSI, the oocyte-corona-cumulus complexes were assessed shortly after retrieval. The complexes were dnnuded by placing them in a medium with 80 IU/ml of hyaluronidase for 5 sec. The cumulus and corona cells were removed mechanically by a set of pipettes with consecutive inner diameters of 220, 200, 180 and 160 µm. According to nuclear maturation grading, the oocytes were classified into categories, metaphase II or non-metaphase II that included oocytes at the metaphase I and germinal vesicle stages. The denuded oocytes were cultured in an M2 culture medium for 3-8 h, and then were examined for the presence of the first polar body. After confirmation of the first polar body, ICSI was performed on the heated stage of an inverted microscope according to Tsai et al. (13). All embryos were scored on the day of embryo transfer for developmental stage and morphology, using the described criteria by Steer et al. (14) and good quality embryos were transferred. A good-quality embryo was defined embryo in G1 and G2 grade, having four blastomeres on day 2 or ≥8 blastomeres on day 3, less than 20% fragmentation, and no multinuclear blastomeres (14).
Luteal phase support (LPS) was started the day after ovum pick up by the vaginal administration of progesterone (Prontogest 200 mg suppositories. Nile Company, Pharmaceuticals, Egypt) thrice daily for 16 days and was continued for up to12 weeks if pregnancy occurred. Pregnancy was diagnosed by measurement of β-HCG level and was confirmed by later transvaginal sonography (TVU) as clinical pregnancy.
- Conditions
- Infertility
- Being tested
- endometrial flushing
- Keywords
- Assisted Reproduction
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endometrial flushingProcedure or surgery
Oocytes were retrieved 34-36 h after hCG administration and aspirated FF was collected and centrifuged at 600 rpm for 10 min and 5-ml sample of supernatant was obtained for ELISA estimation of tumor necrosis factor-α (TNF-α), granulocyte colony-stimulating factor (G-CSF), leptin and anti-Mullerian Hormone (AMH) levels in both groups. The remaining amount was used for endometrial flushing
| Study group | Role | What they receive |
|---|---|---|
| endometrial flushing (A) | Active comparator | Oocytes were retrieved 34-36 h after hCG administration and aspirated FF was collected in a sterile container and was centrifuged at 600 rpm for 10 min at room temperature and a 5-ml sample of the supernatant was obtained for laboratory workup, while the remaining amount of supernatant was used to flush the endometrium through an applied uterine catheter in FF group and was discarded in the other group. Receives: Procedure: endometrial flushing |
| B | No intervention | no intervention Control group included 40 women would not have FF endometrial flushing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rates.
Measured: after retriveal by 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startJan 2013
- Primary completionJun 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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 2/3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khalid abd aziz mohamed, Benha University
- Investigators
- ahmed saad, MD, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468258
- Sponsor's protocol ID
- khalid-khalid 2
- Status last verified
- Sep 2016
- First submitted
- 6 Jun 2015
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-factorial Analysis of the Follicular Fluid Milieu to Explore the Discrepant Effect of Follicular Fluid Endometrial Flushing on Outcome of Assisted Reproduction Trial
- ClinicalTrials.gov ID
- NCT02468258
- Acronym / sponsor ID
- khalid-khalid 2
- Conditions
- Infertility
- Keywords
- Assisted Reproduction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 10 Jun 2015 (estimated)
- 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 \& Methods: Eighty infertile women were randomly categorized into: Group EF (n=40) had EF after oocyte retrieval and Control group (n=40) did not have EF. All women were subjecte to the standard down-regulation regimen followed by controlled ovarian hyper stimulation . Oocytes were retrieved 34-36 h after hCG administration and aspirated FF was collected and centrifuged at 600 rpm for 10 min and 5-ml sample of supernatant was obtained for ELISA estimation of tumor necrosis factor-α (TNF-α), granulocyte colony-stimulating factor (G-CSF), leptin and anti-Mullerian Hormone (AMH) levels in both groups. The remaining amount was used for EF in EF group and was discarded in control group. Pregnancy was diagnosed by measurement of β-HCG level and confirmed by transvaginal sonography as clinical pregnancy
Detailed description
Patients were randomly, using sealed envelops, categorized into two groups. Group EF included 40 women subjected to FF endometrial flushing after oocyte retrieval and Control group included 40 women would not have FF endometrial flushing.
Controlled ovarian stimulation The protocol for controlled ovarian hyperstimulation preceded by the standard down-regulation regimen described by Chang et al., (11). Pituitary down-regulation was evaluated by a determination of serum estradiol (E2), LH concentration and transvaginal sonography of the ovaries. Serum E2 and LH was assayed using a commercially available competitive immunoassay with the Immulite Analyzer (DPC Coat-a Count; Diagnostic Products Corp., USA) at Unit laboratory. All patients received triptorelin acetate (Decapeptyl; Ferring, Germany) 0.1 mg injected subcutaneously once daily, beginning on day 21 of the previous cycle until the 1st day of the next cycle. If the serum E2 level was <35 pg/ml, LH <10 mIU/ml and no follicles >10 mm in diameter were noted on TVS, Decapeptyl was decreased to half a dose and continued until and including the day of hCG administration. If the pituitary was not suppressed, Decapeptyl was continued at the same dose and the serum E2, LH level was rechecked daily until suppression was achieved.
Patients received hMG (Menogon; Ferring Pharamceutical Co, Germany) in a dose of 225 IU/day after pituitary suppression. Gonadotrophin was administered daily for 6 days, after which the dose was individualized according to ovarian follicular growth. Patients were monitored every other day starting on day 6 of stimulation with TVS and serum E2. Intramuscular hCG (Pregnyl; Organon, Holland) 10,000 IU was administered when at least 5 follicles were ≥18 mm in diameter and with adequate serum E2 levels. Progesterone was measured only on the day of hCG administration. Patients were divided into low, moderate and high responders, according to the total dose of hMG used up to the day of hCG injection (12).
Oocytes were retrieved 34-36 h after hCG administration and aspirated FF was collected in a sterile container and was centrifuged at 600 rpm for 10 min at room temperature and a 5-ml sample of the supernatant was obtained for laboratory workup, while the remaining amount of supernatant was used to flush the endometrium through an applied uterine catheter in FF group and was discarded in the other group.
Oocyte preparation For ICSI, the oocyte-corona-cumulus complexes were assessed shortly after retrieval. The complexes were dnnuded by placing them in a medium with 80 IU/ml of hyaluronidase for 5 sec. The cumulus and corona cells were removed mechanically by a set of pipettes with consecutive inner diameters of 220, 200, 180 and 160 µm. According to nuclear maturation grading, the oocytes were classified into categories, metaphase II or non-metaphase II that included oocytes at the metaphase I and germinal vesicle stages. The denuded oocytes were cultured in an M2 culture medium for 3-8 h, and then were examined for the presence of the first polar body. After confirmation of the first polar body, ICSI was performed on the heated stage of an inverted microscope according to Tsai et al. (13). All embryos were scored on the day of embryo transfer for developmental stage and morphology, using the described criteria by Steer et al. (14) and good quality embryos were transferred. A good-quality embryo was defined embryo in G1 and G2 grade, having four blastomeres on day 2 or ≥8 blastomeres on day 3, less than 20% fragmentation, and no multinuclear blastomeres (14).
Luteal phase support (LPS) was started the day after ovum pick up by the vaginal administration of progesterone (Prontogest 200 mg suppositories. Nile Company, Pharmaceuticals, Egypt) thrice daily for 16 days and was continued for up to12 weeks if pregnancy occurred. Pregnancy was diagnosed by measurement of β-HCG level and was confirmed by later transvaginal sonography (TVU) as clinical pregnancy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endometrial flushing (A) | Active comparator | Procedure: endometrial flushingOocytes were retrieved 34-36 h after hCG administration and aspirated FF was collected in a sterile container and was centrifuged at 600 rpm for 10 min at room temperature and a 5-ml sample of the supernatant was obtained for laboratory workup, while the remaining amount of supernatant was used to flush the endometrium through an applied uterine catheter in FF group and was discarded in the other group. |
| B | No intervention | –no intervention Control group included 40 women would not have FF endometrial flushing. |
Who may qualify
- Ages
- 19 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Inclusion criteria included age younger than 37 years, having a regular and proven ovulatory menstrual cycle with a length of 26-35 days and body mass index (BMI) of <35 kg/m2, and serum FSH and estradiol were within normal range. Indications for IVF were tubal pathology, unexplained infertility, and male factor
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| endometrial flushingOocytes were retrieved 34-36 h after hCG administration and aspirated FF was collected and centrifuged at 600 rpm for 10 min and 5-ml sample of supernatant was obtained for ELISA estimation of tumor necrosis factor-α (TNF-α), granulocyte colony-stimulating factor (G-CSF), leptin and anti-Mullerian Hormone (AMH) levels in both groups. The remaining amount was used for endometrial flushing | Procedure or surgery | endometrial flushing (A) |
Primary outcome
pregnancy rates.
Time frame: after retriveal by 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
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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.
ahmed saad, MD principal investigator
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing endometrial flushing in people with 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: withdrawn, as of the sponsor's last update on 20 Sep 2016. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
pregnancy rates. (time frame: after retriveal by 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 20 Sep 2016.