Follicular FluidPhase 3NCT04077970
Intrauterine Flushing With Follicular Fluid Plus Granulosa Cells
A Phase 3 study testing Intrauterine flushing of follicular fluid with granulosa cells in people with Follicular Fluid and Granulosa Cell, run by Royan Institute at 1 site in Iran.
Trial summary
One hundred forty patients with male factor infertility are randomized into two groups. In the study group, flushing the endometrial cavity with 2ml of clear follicular fluid with granulose cells will be performed using an IUI catheter after ovum pick-up While in the control group, no flushing of the endometrial… Read more about this study
- Who is it for?
- Ages 20 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Follicular Fluid, Granulosa Cell, Embryo Implantation
- What is being tested?
- Intrauterine flushing of follicular fluid with granulosa cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteIran
- Study dates
- 1 Nov 2018to 1 Jan 2023
- Phase
- Phase 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 20 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal Hormonal profile (FSH, LH, AMH) and normal AFC
- Normal ovarian reserve
- Age 20-38 years
- Regular menstrual cycle
- IVF / ICSI or IVF or ICSI cycles with agonist and antagonist protocol
- Existence of at least 2 oocytes in dominant follicular fluids
Who cannot join
- Presence of Endometriosis and Endometrioma
- Hydrosalpinx
- OHSS (Ovarian Hyper Stimulating Syndrome)
- Tubal factor infertility
- Male factor infertility with azoospermia
- Low/Poor Response
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- Myoma with a compression effect or submocusa myometrium
- Intra mural or subserouse Myoma > 5cm
- Presence of untreated Thyroid, Diabetic and Hepatitis diseases, vaginal infection.
- Endometrial tuberculosis
- The follicular fluid which contains any oocyte or contaminated with blood will be discarded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Implantation and Clinical Pregnancy After Intrauterine Flushing of Infertile Patients With Follicular Fluid Plus Granulosa Cells- Randomized Controlled Trial
One hundred forty patients with male factor infertility are randomized into two groups. In the study group, flushing the endometrial cavity with 2ml of clear follicular fluid with granulose cells will be performed using an IUI catheter after ovum pick-up While in the control group, no flushing of the endometrial cavity with FF is done. The implantation rates and pregnancy rates in both groups will be assessed.
Read the detailed description
This study is a randomized clinical trial to investigate implantation rate and clinical pregnancy after intrauterine flushing of infertile patients with follicular fluid plus granulosa cells - Randomized controlled trials. The study protocol is approved by the Ethics Committee (Institutional Review Board) of Royan institute and all participants provide informed consent.
The main objective of this study is evaluation of implantation rate and clinical pregnancy after flushing of uterine in infertile patients with follicular fluid plus granulosa cells in IVF/ ICSI cycles.
Material and methods: In a randomized clinical trial, 140 patients with Male factor infertility referring to infertility clinic of Royan Institute, Iran, who received ovarian stimulation with antagonist and agonist protocol, will be randomly assigned to two groups: in case group, if the follicular fluid of two clear dominant follicles contain at least 2 COC, after removal of the COCs, follicular fluid will be collected Endometrial cavity flushing with 2 ml of follicular fluid will be performed by IUI caterer. In control group only catheterization of uterine cavity will be performed. Primary outcome is comparison of implantation rate between case and control group. Secondly outcome is assessment of clinical pregnancy rate in both groups.
- Conditions
- Follicular Fluid, Granulosa Cell, Embryo Implantation
- Being tested
- Intrauterine flushing of follicular fluid with granulosa cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine flushing of follicular fluid with granulosa cellsBiological
All patients in case and control groups will receive agonist and antagonist protocol. Ovarian stimulation will be carried out when pituitary desensitization is achieved and is continued until the day of hCG administration. COCs aspiration will be performed 34-36h after hCG injection. Clear Follicular Fluids (without blood cells) which contain COCs will be used. Endometrial flushing after oocyte retrieval with 2 ml of clear FF plus granulose cells will be performed by an IUI catheter. The control group included 70 women who would not have FF endometrial flushing. In both groups, embryo transfer will be carried out 2-3 days later. Luteal phase support will be started the day after ovum pick up by the vaginal administration of progesterone daily for 16 days and will continued for up to12 weeks if pregnancy occurred. Pregnancy was diagnosed by measurement of β-hCG level and later was confirmed by Transvaginal sonography.
| Study group | Role | What they receive |
|---|---|---|
| Intrauterine flushing follicular fluid | Experimental | Women underwent intrauterine flushing with follicular fluid plus granulosa cells Receives: Biological: Intrauterine flushing of follicular fluid with granulosa cells |
| Without intrauterine flushing with follicular fluid | No intervention | Women without intrauterine flushing with follicular fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation rates
Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred
Measured: Day 35-42 post ovum pick-up (OPU) (34-36 hours post recombinant human choriogonadotropin day [approximately 28 days])
Secondary outcomes (1)
Clinical pregnancy rate
The observation of gestational sac on ultrasound examination two-three weeks after positive serum βhCG
Measured: 4-6 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start1 Nov 2018
- Primary completion1 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Follicular FluidStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Maryam Hafezi, Study chair, Department of Endocrinology and Female Infertility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077970
- Sponsor's protocol ID
- Infertility-Uterine flushing
- Status last verified
- Mar 2023
- First submitted
- 1 Sep 2019
- Last updated
- 14 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hosseini E, Aghajanpour S, Chekini Z, Zameni N, Zolfaghary Z, Aflatoonian R, Hafezi M. An Approach to Improve Endometrial Receptivity: Is It Beneficial to Flush The Uterine Cavity with Follicular Fluid and Granulosa Cells? A Phase III Randomised Clinical Trial. Int J Fertil Steril. 2024 Jul 13;18(Suppl 1):22-29. doi: 10.22074/ijfs.2023.2000897.1461.
PubMed 39033367
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Implantation and Clinical Pregnancy After Intrauterine Flushing of Infertile Patients With Follicular Fluid Plus Granulosa Cells- Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04077970
- Acronym / sponsor ID
- Infertility-Uterine flushing
- Conditions
- Follicular Fluid, Granulosa Cell, Embryo Implantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 4 Sep 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.
One hundred forty patients with male factor infertility are randomized into two groups. In the study group, flushing the endometrial cavity with 2ml of clear follicular fluid with granulose cells will be performed using an IUI catheter after ovum pick-up While in the control group, no flushing of the endometrial cavity with FF is done. The implantation rates and pregnancy rates in both groups will be assessed.
Detailed description
This study is a randomized clinical trial to investigate implantation rate and clinical pregnancy after intrauterine flushing of infertile patients with follicular fluid plus granulosa cells - Randomized controlled trials. The study protocol is approved by the Ethics Committee (Institutional Review Board) of Royan institute and all participants provide informed consent.
The main objective of this study is evaluation of implantation rate and clinical pregnancy after flushing of uterine in infertile patients with follicular fluid plus granulosa cells in IVF/ ICSI cycles.
Material and methods: In a randomized clinical trial, 140 patients with Male factor infertility referring to infertility clinic of Royan Institute, Iran, who received ovarian stimulation with antagonist and agonist protocol, will be randomly assigned to two groups: in case group, if the follicular fluid of two clear dominant follicles contain at least 2 COC, after removal of the COCs, follicular fluid will be collected Endometrial cavity flushing with 2 ml of follicular fluid will be performed by IUI caterer. In control group only catheterization of uterine cavity will be performed. Primary outcome is comparison of implantation rate between case and control group. Secondly outcome is assessment of clinical pregnancy rate in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrauterine flushing follicular fluid | Experimental | Biological: Intrauterine flushing of follicular fluid with granulosa cellsWomen underwent intrauterine flushing with follicular fluid plus granulosa cells |
| Without intrauterine flushing with follicular fluid | No intervention | –Women without intrauterine flushing with follicular fluid |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Normal Hormonal profile (FSH, LH, AMH) and normal AFC
- Normal ovarian reserve
- Age 20-38 years
- Regular menstrual cycle
- IVF / ICSI or IVF or ICSI cycles with agonist and antagonist protocol
Key exclusion criteria (11 listed)
- Presence of Endometriosis and Endometrioma
- Hydrosalpinx
- OHSS (Ovarian Hyper Stimulating Syndrome)
- Tubal factor infertility
- Male factor infertility with azoospermia
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 |
|---|---|---|
| Intrauterine flushing of follicular fluid with granulosa cellsAll patients in case and control groups will receive agonist and antagonist protocol. Ovarian stimulation will be carried out when pituitary desensitization is achieved and is continued until the day of hCG administration. COCs aspiration will be performed 34-36h after hCG injection. Clear Follicular Fluids (without blood cells) which contain COCs will be used. Endometrial flushing after oocyte retrieval with 2 ml of clear FF plus granulose cells will be performed by an IUI catheter. The control group included 70 women who would not have FF endometrial flushing. In both groups, embryo transfer will be carried out 2-3 days later. Luteal phase support will be started the day after ovum pick up by the vaginal administration of progesterone daily for 16 days and will continued for up to12 weeks if pregnancy occurred. Pregnancy was diagnosed by measurement of β-hCG level and later was confirmed by Transvaginal sonography. | Biological | Intrauterine flushing follicular fluid |
Primary outcome
Implantation rates
Time frame: Day 35-42 post ovum pick-up (OPU) (34-36 hours post recombinant human choriogonadotropin day [approximately 28 days])
Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred
1 secondary outcome
Clinical pregnancy rate
Time frame: 4-6 weeks after embryo 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 14 Mar 2023.
- Derived from this study: PubMed 39033367Hosseini E, Aghajanpour S, Chekini Z, Zameni N, Zolfaghary Z, Aflatoonian R, Hafezi M. An Approach to Improve Endometrial Receptivity: Is It Beneficial to Flush The Uterine Cavity with Follicular Fluid and Granulosa Cells? A Phase III Randomised Clinical Trial. Int J Fertil Steril. 2024 Jul 13;18(Suppl 1):22-29. doi: 10.22074/ijfs.2023.2000897.1461.
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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.
Maryam Hafezi study chair
Department of Endocrinology and Female Infertility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intrauterine flushing of follicular fluid with granulosa cells in people with Follicular Fluid and Granulosa Cell, run by Royan Institute at 1 site in Iran.
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 6 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: finished, as of the sponsor's last update on 14 Mar 2023. 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 Iran. 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 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 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?
Implantation rates (time frame: Day 35-42 post ovum pick-up (OPU) (34-36 hours post recombinant human choriogonadotropin day [approximately 28 days])). 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 NCT04077970, which also lists 1 linked publication.
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 14 Mar 2023.