Infertility (IVF Patients)NCT06769789
Evaluation of Pregnancy Outcome with Usage of Drug-free In-vitro Activation of Follicles Ovary
A study testing Drug free invitro activation Ovary in people with Infertility (IVF Patients) and Infertile Females or Females with Ovarian Insufficiency, run by Malihe Mahmoudinia.
Trial summary
This study is the pilot study to evaluate the effect of Drug-free in vitro activation to improve the outcomes of IVF in poor responder women Read more about this study
- Who is it for?
- Ages 21 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility (IVF Patients), Infertile Females or Females with Ovarian Insufficiency
- What is being tested?
- Drug free invitro activation Ovary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2025to 10 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women under 35 years of age who have one of the following characteristics:
- Or poor response to gonadotropins in a previous IVF cycle (fewer than 3 oocytes in a previous IVF cycle)
- Or ovarian reserve test AMH less than 1.1
Who cannot join
- Unwillingness to continue working with the researcher during the procedure
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Pregnancy Outcome in Poor Responder Patients in IVF Cycle with Usage of Drug-free In-vitro Activation of Follicles Ovary
This study is the pilot study to evaluate the effect of Drug-free in vitro activation to improve the outcomes of IVF in poor responder women
Read the detailed description
First, patients who are poor responders based on Poseidon criteria 1, 3 (women under 35 years of age who either have abnormal ovarian reserve tests or have not had an adequate ovarian response in an IVF cycle) are included in the list of poor responders and are consulted after a complete evaluation by a physician. The patient has a history of poor response in previous IVF cycles. After obtaining the patient's consent, the patient undergoes laparoscopy. The laparoscopy procedure will be performed at Milad Infertility Center, which is equipped with a laparoscopy operating room and a laboratory nearby. The procedures will be performed by a single surgical team that includes laparoscopy and infertility flowsheets. After general anesthesia and pre- and post-operative care, double puncture laparoscopy will be performed. Two minor trocars will be placed, which will be held in place by an ovarian grasper. With scissors, a part of the ovarian cortex is first separated from the underlying medulla and strips of cortex 1 to 2 mm thick and 10 mm long are removed. They are immediately transferred to the adjacent laboratory. A 1 x 5 mm sample from the removed piece is used for histological examination and determination of the number of remaining follicles. The tissue is then divided into 1 x 1 x 1 mm pieces. The removal site will be sutured in case of bleeding. The preparation of the ovary into small pieces will be performed by a single physician for all patients. The prepared pieces are immediately transferred to the operating room. Then the surgeon places the prepared pieces in the tunnel between the cortex and medulla in the opposite ovary and then sutured. The patient is then followed up and immediately treated with FSH (Sinagene Company, Tehran, Iran) at a maximum dose of 300 units, and then the dose is adjusted according to the ovarian response. When a 12 mm follicle is observed, 0.25 mg of Sterotide (Merck Serono, Mississauga, Canada) is started. When the size of 1 or 2 follicles reaches 16, 10,000 units of HCG (Puyish Daru Company, Tehran, Iran) and two ampoules of Deca (Decapeptyl 0.2 mg, Ferring, Germany) are given together for triggering. Ovulation is performed 36 hours later under transvaginal ultrasound guidance.
- Being tested
- Drug free invitro activation Ovary
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug free invitro activation OvaryOther
Drug free invitro activation Ovary
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Drug -free invitro activation of ovary in women | Experimental | Not described Receives: Other: Drug free invitro activation Ovary |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of oocytes obtained at oocyte pick-up (OPU)
Measured: Within 3 weeks after ovarian stimulation
Number of embryos
Measured: Within 3 weeks after ovarian stimulation
Quality of embryos at the end of IVF treatment
A grade embryo was defined to have four blastomeres on the second day and seven or eight blastomeres on the third day with equal size and <20% fragmentation (high quality). Blastocyst embryos were assessed according to Gardner's criteria.
Measured: Within 3 weeks after ovarian stimulation
Secondary outcomes (3)
Implantation rate
Measured: 4-8 weeks after transfer
Clinical pregnancy rate
Measured: one month after transfer
Miscarriage rate
Measured: 20 weeks after transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start10 Jan 2025 (estimated)
- Primary completion10 Jan 2026 (estimated)
- Study completion10 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility (IVF Patients)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malihe Mahmoudinia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Malihe Mahmoudinia, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769789
- Sponsor's protocol ID
- IR.MUMS.IRH.REC.1403.127
- Status last verified
- Dec 2024
- First submitted
- 22 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pregnancy Outcome in Poor Responder Patients in IVF Cycle with Usage of Drug-free In-vitro Activation of Follicles Ovary
- ClinicalTrials.gov ID
- NCT06769789
- Acronym / sponsor ID
- IR.MUMS.IRH.REC.1403.127
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Malihe MahmoudiniaUniversity, hospital or other
- Study start
- 10 Jan 2025 (estimated)
- Primary completion
- 10 Jan 2026 (estimated)
- Study completion
- 10 Jan 2027 (estimated)
- First posted
- 10 Jan 2025 (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 study is the pilot study to evaluate the effect of Drug-free in vitro activation to improve the outcomes of IVF in poor responder women
Detailed description
First, patients who are poor responders based on Poseidon criteria 1, 3 (women under 35 years of age who either have abnormal ovarian reserve tests or have not had an adequate ovarian response in an IVF cycle) are included in the list of poor responders and are consulted after a complete evaluation by a physician. The patient has a history of poor response in previous IVF cycles. After obtaining the patient's consent, the patient undergoes laparoscopy. The laparoscopy procedure will be performed at Milad Infertility Center, which is equipped with a laparoscopy operating room and a laboratory nearby. The procedures will be performed by a single surgical team that includes laparoscopy and infertility flowsheets. After general anesthesia and pre- and post-operative care, double puncture laparoscopy will be performed. Two minor trocars will be placed, which will be held in place by an ovarian grasper. With scissors, a part of the ovarian cortex is first separated from the underlying medulla and strips of cortex 1 to 2 mm thick and 10 mm long are removed. They are immediately transferred to the adjacent laboratory. A 1 x 5 mm sample from the removed piece is used for histological examination and determination of the number of remaining follicles. The tissue is then divided into 1 x 1 x 1 mm pieces. The removal site will be sutured in case of bleeding. The preparation of the ovary into small pieces will be performed by a single physician for all patients. The prepared pieces are immediately transferred to the operating room. Then the surgeon places the prepared pieces in the tunnel between the cortex and medulla in the opposite ovary and then sutured. The patient is then followed up and immediately treated with FSH (Sinagene Company, Tehran, Iran) at a maximum dose of 300 units, and then the dose is adjusted according to the ovarian response. When a 12 mm follicle is observed, 0.25 mg of Sterotide (Merck Serono, Mississauga, Canada) is started. When the size of 1 or 2 follicles reaches 16, 10,000 units of HCG (Puyish Daru Company, Tehran, Iran) and two ampoules of Deca (Decapeptyl 0.2 mg, Ferring, Germany) are given together for triggering. Ovulation is performed 36 hours later under transvaginal ultrasound guidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Drug -free invitro activation of ovary in women | Experimental | Other: Drug free invitro activation Ovary |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women under 35 years of age who have one of the following characteristics:
- Or poor response to gonadotropins in a previous IVF cycle (fewer than 3 oocytes in a previous IVF cycle)
- Or ovarian reserve test AMH less than 1.1
Key exclusion criteria (1 listed)
- Unwillingness to continue working with the researcher during the procedure
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 |
|---|---|---|
| Drug free invitro activation OvaryDrug free invitro activation Ovary | Other | Experimental: Drug -free invitro activation of ovary in women |
Primary outcome
The number of oocytes obtained at oocyte pick-up (OPU)
Time frame: Within 3 weeks after ovarian stimulation
Number of embryos
Time frame: Within 3 weeks after ovarian stimulation
Quality of embryos at the end of IVF treatment
Time frame: Within 3 weeks after ovarian stimulation
A grade embryo was defined to have four blastomeres on the second day and seven or eight blastomeres on the third day with equal size and <20% fragmentation (high quality). Blastocyst embryos were assessed according to Gardner's criteria.
3 secondary outcomes
Implantation rate
Time frame: 4-8 weeks after transfer
Clinical pregnancy rate
Time frame: one month after transfer
Miscarriage rate
Time frame: 20 weeks after transfer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Drug free invitro activation Ovary in people with Infertility (IVF Patients) and Infertile Females or Females with Ovarian Insufficiency, run by Malihe Mahmoudinia.
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 3 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: opening soon, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Malihe Mahmoudinia (_+98513338801, Mahmoudiniam@mums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of oocytes obtained at oocyte pick-up (OPU) (time frame: Within 3 weeks after ovarian stimulation). The study lists 3 primary outcomes in all. 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 10 Jan 2025.