InfertilityPhase 3NCT02251925
Frozen Embryo Transfer in Natural and Hormonal Replacement Cycles
A Phase 3 study testing frozen Embryo transfer, 10,000U hCG injection and GnRH agonist (Superfact) in people with Infertility, run by Royan Institute at 1 site in Iran.
Trial summary
This study is a prospective randomized controlled trial to compare the pregnancy outcomes of frozen embryo transfer in natural and hormonal replacement cycles. The study population consisted of all infertile women with regular menstrual cycles who will undergo IVF/ICSI and frozen embryo transfer in Reproductive… Read more about this study
- Who is it for?
- Ages 20 to 37 years
- Conditions the study is for
- Infertility
- What is being tested?
- frozen Embryo transfer, 10,000U hCG injection and GnRH agonist (Superfact)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteIran
- Study dates
- Sep 2012to Nov 2015
- 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 37 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with regular mensturation cycles
- Age 20-37 years
- Patients who underwent long protocol
- Body mass index (BMI) ≤ 30 kg/m2
- Patients who will undergo frozen embryo transfer for the first time
Who cannot join
- Oocyte or embryo donation cycles
- Uterine diseases or malformations
- Hyper prolactinemia
- Thyroid disorders
- Tuberculosis
- Recurrent abortion history
- Severe endometriosis
- Ovulation disorders
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Royan Institute
Tehran
Nasser Aghdami, MD,PhD, (+98)212356000 ext. 516, nasser.aghdami@royaninstitute.org
Leila Arab, MD, (+98)23562000 ext. 414, Leara91@gmail.com
About this study
Official title: Comparison of Pregnancy Outcomes in Frozen Embryo Transfer in Natural and Hormonal Replacement Cycles: a Randomized Controlled Trial
This study is a prospective randomized controlled trial to compare the pregnancy outcomes of frozen embryo transfer in natural and hormonal replacement cycles. The study population consisted of all infertile women with regular menstrual cycles who will undergo IVF/ICSI and frozen embryo transfer in Reproductive Biomedicine Research Center, Royan institute, Tehran Iran.
Read the detailed description
In this study all patients who will undergo frozen embryo transfer are randomly allocated to be prepared for transfer by using either natural cycle (with or without hCG for ovulation induction) or Hormonal cycle (with or without administration of GnRH-a) In natural cycle without hCG, daily monitoring of urinary LH is started from day eight of the cycle and frozen-thawed embryo transfer is planned 3-5 days after detection of LH surge, observing mature follicles in ultrasound and endometrial thickness over 7mm for cleavage embryos.
In natural cycle with hCG, after detection of mature follicles in ultrasound and endometrial thickness over 7mm, 10,000IU hCG is injected for ovulation and embryo transfer is performed 3-5 days later in cleavage stage.
In group 3, injection of GnRH agonist (Superfact) at a subcutaneous daily dose of 0.5 mg is started on the day 17-19 of the natural menstrual cycle. Once pituitary desensitization is confirmed, hormonal treatment is commenced with 4mg/day oral Estradiol valerate and after 7 days if endometrial thickness is adequate, Estradiol administration will be continued with the same dose and 100mg Progesterone is administered before embryo transfer, otherwise patients are candidates for higher dosage of Estradiol till favourable endometrial thickness is achieved.
In the hormonal group without GnRH-a, endometrial preparation will be started with daily administration of 6 mg Estradiol valerate from the 2nd day of the natural menstrual cycle for 6 days. Then treatment will be continued similar to the 3rd group.
- Conditions
- Infertility
- Being tested
- frozen Embryo transfer, 10,000U hCG injection, GnRH agonist (Superfact), administration of 6 mg Estradiol valerate
- Keywords
- infertility froze emberyo transfer hormone replacement
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
frozen Embryo transferBiological
In this study all patients who will undergo frozen embryo transfer are randomly allocated to be prepared for transfer by using either natural cycle (with or without hCG for ovulation induction) or Hormonal cycle (with or without administration of GnRH-a).
10,000U hCG injectionDrug
In natural cycle with hCG, after detection of mature follicles in ultrasound and endometrial thickness over 7mm, 10,000IU hCG is injected for ovulation and embryo transfer is performed 3-5 days later in cleavage stage.
GnRH agonist (Superfact)Drug
In group 3, injection of GnRH agonist (Superfact) at a subcutaneous daily dose of 0.5 mg is started on the day 17-19 of the natural menstrual cycle. Once pituitary desensitization is confirmed, hormonal treatment is commenced with 4mg/day oral Estradiol valerate and after 7 days if endometrial thickness is adequate, Estradiol administration will be continued with the same dose and 100mg Progesterone is administered before embryo transfer, otherwise patients are candidates for higher dosage of Estradiol till favourable endometrial thickness is achieved.
administration of 6 mg Estradiol valerateDrug
In the hormonal group without GnRH-a, endometrial preparation will be started with daily administration of 6 mg Estradiol valerate from the 2nd day of the natural menstrual cycle for 6 days. Then treatment will be continued similar to the 3rd group.
| Study group | Role | What they receive |
|---|---|---|
| Natural cycle | Experimental | In natural cycle without hCG, daily monitoring of urinary LH is started from day eight of the cycle and frozen-thawed embryo transfer is planned 3-5 days after detection of LH surge, observing mature follicles in ultrasound and endometrial thickness over 7mm for cleavage embryos. Receives: Biological: frozen Embryo transfer |
| Natural cycle + hCG for ovulation induction | Experimental | In natural cycle with hCG, after detection of mature follicles in ultrasound and endometrial thickness over 7mm, 10,000IU hCG is injected for ovulation and embryo transfer is performed 3-5 days later in cleavage stage. Receives: Biological: frozen Embryo transfer; Drug: 10,000U hCG injection |
| Hormonally controlled cycle with GnRH-a | Experimental | In this group , injection of GnRH agonist (Superfact) at a subcutaneous daily dose of 0.5 mg is started on the day 17-19 of the natural menstrual cycle. Once pituitary desensitization is confirmed, hormonal treatment is commenced with 4mg/day oral Estradiol valerate and after 7 days if endometrial thickness is adequate, Estradiol administration will be continued with the same dose and 100mg Progesterone is administered before embryo transfer, otherwise patients are candidates for higher dosage of Estradiol till favourable endometrial thickness is achieved. Receives: Biological: frozen Embryo transfer; Drug: GnRH agonist (Superfact) |
| Hormonally controlled cycle without GnRH-a | Experimental | In the hormonal group without GnRH-a, endometrial preparation will be started with daily administration of 6 mg Estradiol valerate from the 2nd day of the natural menstrual cycle for 6 days. Then treatment will be continued similar to the 3rd group. Receives: Biological: frozen Embryo transfer; Drug: administration of 6 mg Estradiol valerate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
The pregnancy rate will be evaluated in patients of each groups 4-6 weeks after embryo transfer.
Measured: 4 weeks
Secondary outcomes (4)
Implantation rate
Evaluation the implantation rate in patients of each groups 4-6 weeks after frozen embryo transfer
Measured: 4 weeks
chemical pregnancy rates
Evaluation the chemical pregnancy rates in patients of each group 2 weeks after embryo transfer.
Measured: 2 weeks
Ongoing pregnancy
Evaluation the ongoing pregnancy in patients of each group 12 weeks after embryo transfer.
Measured: 12 weeks
miscarriage rate
Evaluation the miscarriage rate in patients of each group 12 weeks after embryo transfer.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startSep 2012
- Primary completionOct 2015 (estimated)
- Study completionNov 2015 (estimated)
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hamid Gourabi, PhD, Study chair, Head of Royan InstituteTahereh Madani, MD, Study director, Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, IranLadan Mohammadi Yeganeh, MSC, Principal investigator, Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251925
- Sponsor's protocol ID
- Royan-Emb-019
- Status last verified
- Apr 2012
- First submitted
- 23 Sep 2014
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Madani T, Ramezanali F, Yahyaei A, Hasani F, Bagheri Lankarani N, Mohammadi Yeganeh L. Live birth rates after different endometrial preparation methods in frozen cleavage-stage embryo transfer cycles: a randomized controlled trial. Arch Gynecol Obstet. 2019 Apr;299(4):1185-1191. doi: 10.1007/s00404-019-05062-7. Epub 2019 Feb 1.
PubMed 30707360
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pregnancy Outcomes in Frozen Embryo Transfer in Natural and Hormonal Replacement Cycles: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02251925
- Acronym / sponsor ID
- Royan-Emb-019
- Conditions
- Infertility
- Keywords
- infertility froze emberyo transfer hormone replacement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Sep 2012
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 29 Sep 2014 (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.
This study is a prospective randomized controlled trial to compare the pregnancy outcomes of frozen embryo transfer in natural and hormonal replacement cycles. The study population consisted of all infertile women with regular menstrual cycles who will undergo IVF/ICSI and frozen embryo transfer in Reproductive Biomedicine Research Center, Royan institute, Tehran Iran.
Detailed description
In this study all patients who will undergo frozen embryo transfer are randomly allocated to be prepared for transfer by using either natural cycle (with or without hCG for ovulation induction) or Hormonal cycle (with or without administration of GnRH-a) In natural cycle without hCG, daily monitoring of urinary LH is started from day eight of the cycle and frozen-thawed embryo transfer is planned 3-5 days after detection of LH surge, observing mature follicles in ultrasound and endometrial thickness over 7mm for cleavage embryos.
In natural cycle with hCG, after detection of mature follicles in ultrasound and endometrial thickness over 7mm, 10,000IU hCG is injected for ovulation and embryo transfer is performed 3-5 days later in cleavage stage.
In group 3, injection of GnRH agonist (Superfact) at a subcutaneous daily dose of 0.5 mg is started on the day 17-19 of the natural menstrual cycle. Once pituitary desensitization is confirmed, hormonal treatment is commenced with 4mg/day oral Estradiol valerate and after 7 days if endometrial thickness is adequate, Estradiol administration will be continued with the same dose and 100mg Progesterone is administered before embryo transfer, otherwise patients are candidates for higher dosage of Estradiol till favourable endometrial thickness is achieved.
In the hormonal group without GnRH-a, endometrial preparation will be started with daily administration of 6 mg Estradiol valerate from the 2nd day of the natural menstrual cycle for 6 days. Then treatment will be continued similar to the 3rd group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Natural cycle | Experimental | Biological: frozen Embryo transferIn natural cycle without hCG, daily monitoring of urinary LH is started from day eight of the cycle and frozen-thawed embryo transfer is planned 3-5 days after detection of LH surge, observing mature follicles in ultrasound and endometrial thickness over 7mm for cleavage embryos. |
| Natural cycle + hCG for ovulation induction | Experimental | Biological: frozen Embryo transfer, Drug: 10,000U hCG injectionIn natural cycle with hCG, after detection of mature follicles in ultrasound and endometrial thickness over 7mm, 10,000IU hCG is injected for ovulation and embryo transfer is performed 3-5 days later in cleavage stage. |
| Hormonally controlled cycle with GnRH-a | Experimental | Biological: frozen Embryo transfer, Drug: GnRH agonist (Superfact)In this group , injection of GnRH agonist (Superfact) at a subcutaneous daily dose of 0.5 mg is started on the day 17-19 of the natural menstrual cycle. Once pituitary desensitization is confirmed, hormonal treatment is commenced with 4mg/day oral Estradiol valerate and after 7 days if endometrial thickness is adequate, Estradiol administration will be continued with the same dose and 100mg Progesterone is administered before embryo transfer, otherwise patients are candidates for higher dosage of Estradiol till favourable endometrial thickness is achieved. |
| Hormonally controlled cycle without GnRH-a | Experimental | Biological: frozen Embryo transfer, Drug: administration of 6 mg Estradiol valerateIn the hormonal group without GnRH-a, endometrial preparation will be started with daily administration of 6 mg Estradiol valerate from the 2nd day of the natural menstrual cycle for 6 days. Then treatment will be continued similar to the 3rd group. |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with regular mensturation cycles
- Age 20-37 years
- Patients who underwent long protocol
- Body mass index (BMI) ≤ 30 kg/m2
- Patients who will undergo frozen embryo transfer for the first time
Key exclusion criteria (8 listed)
- Oocyte or embryo donation cycles
- Uterine diseases or malformations
- Hyper prolactinemia
- Thyroid disorders
- Tuberculosis
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 |
|---|---|---|
| frozen Embryo transferIn this study all patients who will undergo frozen embryo transfer are randomly allocated to be prepared for transfer by using either natural cycle (with or without hCG for ovulation induction) or Hormonal cycle (with or without administration of GnRH-a). | Biological | Hormonally controlled cycle with GnRH-a, Hormonally controlled cycle without GnRH-a, Natural cycle, Natural cycle + hCG for ovulation induction |
| 10,000U hCG injectionIn natural cycle with hCG, after detection of mature follicles in ultrasound and endometrial thickness over 7mm, 10,000IU hCG is injected for ovulation and embryo transfer is performed 3-5 days later in cleavage stage. | Drug | Natural cycle + hCG for ovulation induction |
| GnRH agonist (Superfact)In group 3, injection of GnRH agonist (Superfact) at a subcutaneous daily dose of 0.5 mg is started on the day 17-19 of the natural menstrual cycle. Once pituitary desensitization is confirmed, hormonal treatment is commenced with 4mg/day oral Estradiol valerate and after 7 days if endometrial thickness is adequate, Estradiol administration will be continued with the same dose and 100mg Progesterone is administered before embryo transfer, otherwise patients are candidates for higher dosage of Estradiol till favourable endometrial thickness is achieved. | Drug | Hormonally controlled cycle with GnRH-a |
| administration of 6 mg Estradiol valerateIn the hormonal group without GnRH-a, endometrial preparation will be started with daily administration of 6 mg Estradiol valerate from the 2nd day of the natural menstrual cycle for 6 days. Then treatment will be continued similar to the 3rd group. | Drug | Hormonally controlled cycle without GnRH-a |
Primary outcome
Clinical pregnancy rate
Time frame: 4 weeks
The pregnancy rate will be evaluated in patients of each groups 4-6 weeks after embryo transfer.
4 secondary outcomes
Implantation rate
Time frame: 4 weeks
chemical pregnancy rates
Time frame: 2 weeks
Ongoing pregnancy
Time frame: 12 weeks
miscarriage rate
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Derived from this study: PubMed 30707360Madani T, Ramezanali F, Yahyaei A, Hasani F, Bagheri Lankarani N, Mohammadi Yeganeh L. Live birth rates after different endometrial preparation methods in frozen cleavage-stage embryo transfer cycles: a randomized controlled trial. Arch Gynecol Obstet. 2019 Apr;299(4):1185-1191. doi: 10.1007/s00404-019-05062-7. Epub 2019 Feb 1.
- Related InfoLink provided by the sponsor.
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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.
Hamid Gourabi, PhD study chair
Head of Royan Institute
Tahereh Madani, MD study director
Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
Ladan Mohammadi Yeganeh, MSC principal investigator
Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
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 frozen Embryo transfer, 10,000U hCG injection and GnRH agonist (Superfact) in people with Infertility, 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 6 May 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nasser Aghdami, MD,PhD ((+98)23562000 ext. 516, nasser.aghdami@royaninstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 4 weeks). 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 NCT02251925, 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 6 May 2015.