AzTrials
AzTrials

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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

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.

Egypt1 site
  • Banha Universty

    Banhā, El Qalubia, 13518

Other trials in Egypt

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 groups in NCT02468258
Study groupRoleWhat they receive
endometrial flushing (A)Active comparatorOocytes 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
BNo interventionno 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.

  1. 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.

  1. First posted10 Jun 2015 (estimated)
  2. Study startJan 2013
  3. Primary completionJun 2017 (estimated)
  4. Study completionJul 2017 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in