IVFNCT04522479
Prolonged Protocol of Early Follicular or Mid Luteal Phase
A study testing Change the injection time of long acting GnRH-a in people with IVF, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
Due to the injection of gonadotropin releasing hormone agonist (GnRH-a) before controlled ovarian hyperstimulation (COH), the scheme of prolonged early follicular period protocol has obvious advantages in achieving ideal egg number, increasing endometrial receptivity to embryo transfer, inhibiting endogenous… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- IVF
- What is being tested?
- Change the injection time of long acting GnRH-a
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,150 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2020to 13 May 2024
- Phase
- Interventional
- 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 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Tubal factor infertility;
- polycystic ovary (PCO) or polycystic ovary syndrome (PCOS) patients;
- Patients of mild to moderate endometriosis；
- Oligoasthenospermia in male；
- More than 5 antral follicle count (AFC) on both ovaries；
- Unexplained infertility: there is a history of no contraception and pregnancy for more than 1 year, no clear cause of infertility such as ovulation, fallopian tube, endometrium and male factors is found, or the above factors return to normal after treatment.
Who cannot join
- History of adverse pregnancy and childbirth；
- Unilateral ovariectomy；
- Uterine malformation, intrauterine adhesion, submucous myoma；
- Chromosomal abnormality of both husband and wife；
- Patients with contraindications of assisted reproductive technology or pregnancy: such as uncontrolled diabetes mellitus, undiagnosed liver and kidney dysfunction, history of deep vein thrombosis, history of pulmonary embolism, history of cerebrovascular accident, uncontrolled hypertension, heart disease, suspected cervical cancer, endometrial cancer, breast cancer or previous history, undetermined vaginal bleeding;
- Unable to be regularly follow up；
- Participating in other clinical trials；
- No fresh single blastocyst transfer.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027
Yingfen Ying
About this study
Official title: Comparison of Efficacy and Safety of Controlled Hyperstimulation of Prolonged Protocol in Early Follicular or Mid Luteal Phase: a Single Center, Randomized, Controlled Trial
Due to the injection of gonadotropin releasing hormone agonist (GnRH-a) before controlled ovarian hyperstimulation (COH), the scheme of prolonged early follicular period protocol has obvious advantages in achieving ideal egg number, increasing endometrial receptivity to embryo transfer, inhibiting endogenous luteinizing hormone (LH) peak and reducing cycle cancellation rate. The full dose of long acting GnRH-a was also applied before COH in the mid luteal Hypergrowth program, and the mechanism of its lowering tone was similar. But whether the clinical and perinatal outcome of early follicular hyperlengthening is as effective as that of mid luteal hyperlengthening has not been reported at home and abroad. Moreover, there is a lack of prospective randomized controlled studies.
Read the detailed description
One injection of 3.75mg GnRHa was injected on the 1st-3rd or 21st-23rd day of menstruation. The level of estradiol (E2), progesterone (P), luteinizing hormone (LH) in peripheral blood and the number of follicles in bilateral ovarian internal sinuses were monitored on the 32nd-38th day after pituitary hyporegulation.Gonadotropin (Gn) will be given after pituitary desensitization. When the diameter of at least two follicles ≥ 18mm or more than three follicles ≥ 17mm, the trigger of human chorionic gonadotropin (hCG) will be given and oocyte will be retrieved. The selective fresh single blastocyst transplantation will be carried out on the 4th-6th day after oocyte retrieval. HCG test at 12nd day after transplatation. Follow-up investigation will given during the pregnancy and perinatal period.
- Conditions
- IVF
- Being tested
- Change the injection time of long acting GnRH-a
- Keywords
- prolonged protocol, In vitro fertilization (IVF), Intracytoplasmic sperm injection (ICSI), single blastocyst transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change the injection time of long acting GnRH-aOther
The whole dose of long acting GnRH-a drug was changed to be injected on day 21st-23rd day of menstruation
| Study group | Role | What they receive |
|---|---|---|
| prolonged protocol of early follicular phase | No intervention | Inject a full dose of GnRH-a in 1st-3rd day of menstruation (leuprorelin acetate, injection, 3.75mg), the level of E2, P, LH in peripheral blood and the number of follicles in bilateral internal ovarian sinuses were monitored 32-38 days after the depression. If the pituitary desensitization was achieved, Gn (recombinant human follicle stimulating hormone or urofollicle stimulating hormone, injection, 75-300iu) was used for contralled hyperstimulation, when the diameter of 2 follicles was ≥ 18mm，hCG (human chorionic gonadotropin, injection, 4000-10000IU) was used to trigger and retrieve the oocyte. Selective single blastocyst transplantation was performed on the 4th-6th day after the oocyte retrieved. β-hCG was detected on the 12th day after embryo transplantation, and pregnancy or not was judged. If patients get pregnancy, follow-up was continued until the 42nd day after baby delivery. |
| prolonged protocol of middle luteal phase | Experimental | Inject a full dose of GnRH-a in 21st-23rd day of menstruation (leuprorelin acetate, injection, 3.75mg), the level of E2, P, LH in peripheral blood and the number of follicles in bilateral internal ovarian sinuses were monitored 32-38 days after the depression. If the pituitary desensitization was achieved, Gn (recombinant human follicle stimulating hormone or urofollicle stimulating hormone, injection, 75-300iu) was used for contralled hyperstimulation, when the diameter of 2 follicles was ≥ 18mm，hCG (human chorionic gonadotropin, injection, 4000-10000IU) was used to trigger and retrieve the oocyte. Selective single blastocyst transplantation was performed on the 4th-6th day after the oocyte retrieved. β-hCG was detected on the 12th day after embryo transplantation, and pregnancy or not was judged. If patients get pregnancy, follow-up was continued until the 42nd day after baby delivery. Receives: Other: Change the injection time of long acting GnRH-a |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate
live birth rate per transplantation cycle
Measured: live birth of more than 28 pregnancy weeks
Secondary outcomes (5)
clinical pregnancy rate
fetal heart beat confirmed by transvaginal ultrasound
Measured: fetal heart beat confirmed by transvaginal ultrasound 26-35 days after embryo transplantation
good quality blastocyst rate
formation rate of more than 4BB Blastocyst
Measured: The ratio of good quality blastocysts above 4BB degree 4-6 days after oocyte collection
Incidence rate of early on-set severe ovarian hyperstimulation syndrome (OHSS)
Severe ovarian hyperstimulation syndrome according to Golan standard
Measured: Severe ovarian hyperstimulation syndrome according to Golan standard within 7 days after ovum removal
Early misscarage rate
Transvaginal sonography identified patients with abortion after clinical pregnancy
Measured: Abortion before 12 pregnancy weeks
Perinatal complications
Perinatal complications of mothers and fetus
Measured: Incidence rate of mother and child complications from pregnancy to postpartum in 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start13 May 2020
- Primary completion13 May 2023 (estimated)
- Study completion13 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The early follicular and mid luteal prolonged regimens were randomly enrolled in a ratio of 1 to 1
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yingfen Ying, Principal investigator, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522479
- Sponsor's protocol ID
- SAHoWMU-CR2019-07-115
- Status last verified
- Aug 2020
- First submitted
- 17 Jul 2020
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety of Controlled Hyperstimulation of Prolonged Protocol in Early Follicular or Mid Luteal Phase: a Single Center, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04522479
- Acronym / sponsor ID
- SAHoWMU-CR2019-07-115
- Conditions
- IVF
- Keywords
- prolonged protocol, In vitro fertilization (IVF), Intracytoplasmic sperm injection (ICSI), single blastocyst transfer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,150 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 13 May 2020 (actual)
- Primary completion
- 13 May 2023 (estimated)
- Study completion
- 13 May 2024 (estimated)
- First posted
- 21 Aug 2020 (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.
Due to the injection of gonadotropin releasing hormone agonist (GnRH-a) before controlled ovarian hyperstimulation (COH), the scheme of prolonged early follicular period protocol has obvious advantages in achieving ideal egg number, increasing endometrial receptivity to embryo transfer, inhibiting endogenous luteinizing hormone (LH) peak and reducing cycle cancellation rate. The full dose of long acting GnRH-a was also applied before COH in the mid luteal Hypergrowth program, and the mechanism of its lowering tone was similar. But whether the clinical and perinatal outcome of early follicular hyperlengthening is as effective as that of mid luteal hyperlengthening has not been reported at home and abroad. Moreover, there is a lack of prospective randomized controlled studies.
Detailed description
One injection of 3.75mg GnRHa was injected on the 1st-3rd or 21st-23rd day of menstruation. The level of estradiol (E2), progesterone (P), luteinizing hormone (LH) in peripheral blood and the number of follicles in bilateral ovarian internal sinuses were monitored on the 32nd-38th day after pituitary hyporegulation.Gonadotropin (Gn) will be given after pituitary desensitization. When the diameter of at least two follicles ≥ 18mm or more than three follicles ≥ 17mm, the trigger of human chorionic gonadotropin (hCG) will be given and oocyte will be retrieved. The selective fresh single blastocyst transplantation will be carried out on the 4th-6th day after oocyte retrieval. HCG test at 12nd day after transplatation. Follow-up investigation will given during the pregnancy and perinatal period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The early follicular and mid luteal prolonged regimens were randomly enrolled in a ratio of 1 to 1
| Arm | Type | Receives |
|---|---|---|
| prolonged protocol of early follicular phase | No intervention | –Inject a full dose of GnRH-a in 1st-3rd day of menstruation (leuprorelin acetate, injection, 3.75mg), the level of E2, P, LH in peripheral blood and the number of follicles in bilateral internal ovarian sinuses were monitored 32-38 days after the depression. If the pituitary desensitization was achieved, Gn (recombinant human follicle stimulating hormone or urofollicle stimulating hormone, injection, 75-300iu) was used for contralled hyperstimulation, when the diameter of 2 follicles was ≥ 18mm，hCG (human chorionic gonadotropin, injection, 4000-10000IU) was used to trigger and retrieve the oocyte. Selective single blastocyst transplantation was performed on the 4th-6th day after the oocyte retrieved. β-hCG was detected on the 12th day after embryo transplantation, and pregnancy or not was judged. If patients get pregnancy, follow-up was continued until the 42nd day after baby delivery. |
| prolonged protocol of middle luteal phase | Experimental | Other: Change the injection time of long acting GnRH-aInject a full dose of GnRH-a in 21st-23rd day of menstruation (leuprorelin acetate, injection, 3.75mg), the level of E2, P, LH in peripheral blood and the number of follicles in bilateral internal ovarian sinuses were monitored 32-38 days after the depression. If the pituitary desensitization was achieved, Gn (recombinant human follicle stimulating hormone or urofollicle stimulating hormone, injection, 75-300iu) was used for contralled hyperstimulation, when the diameter of 2 follicles was ≥ 18mm，hCG (human chorionic gonadotropin, injection, 4000-10000IU) was used to trigger and retrieve the oocyte. Selective single blastocyst transplantation was performed on the 4th-6th day after the oocyte retrieved. β-hCG was detected on the 12th day after embryo transplantation, and pregnancy or not was judged. If patients get pregnancy, follow-up was continued until the 42nd day after baby delivery. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Tubal factor infertility;
- polycystic ovary (PCO) or polycystic ovary syndrome (PCOS) patients;
- Patients of mild to moderate endometriosis；
- Oligoasthenospermia in male；
- More than 5 antral follicle count (AFC) on both ovaries；
Key exclusion criteria (8 listed)
- History of adverse pregnancy and childbirth；
- Unilateral ovariectomy；
- Uterine malformation, intrauterine adhesion, submucous myoma；
- Chromosomal abnormality of both husband and wife；
- Patients with contraindications of assisted reproductive technology or pregnancy: such as uncontrolled diabetes mellitus, undiagnosed liver and kidney dysfunction, history of deep vein thrombosis, history of pulmonary embolism, history of cerebrovascular accident, uncontrolled hypertension, heart disease, suspected cervical cancer, endometrial cancer, breast cancer or previous history, undetermined vaginal bleeding;
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 |
|---|---|---|
| Change the injection time of long acting GnRH-aThe whole dose of long acting GnRH-a drug was changed to be injected on day 21st-23rd day of menstruation | Other | prolonged protocol of middle luteal phase |
Primary outcome
live birth rate
Time frame: live birth of more than 28 pregnancy weeks
live birth rate per transplantation cycle
5 secondary outcomes
clinical pregnancy rate
Time frame: fetal heart beat confirmed by transvaginal ultrasound 26-35 days after embryo transplantation
good quality blastocyst rate
Time frame: The ratio of good quality blastocysts above 4BB degree 4-6 days after oocyte collection
Incidence rate of early on-set severe ovarian hyperstimulation syndrome (OHSS)
Time frame: Severe ovarian hyperstimulation syndrome according to Golan standard within 7 days after ovum removal
Early misscarage rate
Time frame: Abortion before 12 pregnancy weeks
Perinatal complications
Time frame: Incidence rate of mother and child complications from pregnancy to postpartum in 42 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
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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.
Yingfen Ying principal investigator
Second Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Change the injection time of long acting GnRH-a in people with IVF, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
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 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 21 Aug 2020. 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 China. 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.
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 Yingfen Ying (+086-13732091230, 1192108952@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live birth rate (time frame: live birth of more than 28 pregnancy weeks). 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 21 Aug 2020.