Infertility Clinical Trial
Official title:
The Effectiveness of Intracytoplasmic Sperm Injection Versus Conventional in Vitro Fertilization in Couples With Non-male Factor Infertility: a Randomized Controlled Trial
Conventionally, ICSI was initially developed and has been shown to be an effective treatment for male factor infertility. It is increasingly being used for patients without a male factor diagnosis, despite the lack of clinical evidence to support its use. Moreover, ICSI is an invasive and expensive procedure. This multi-center, randomized, controlled, parallel-group trial will be conducted to compare the effectiveness of ICSI versus conventional IVF in infertile couples scheduled for IVF treatment, in whom the male partner has normal sperm.
All patients undergoing IVF/ICSI will be treated with a GnRH antagonist protocol. Recombinant
FSH (Puregon, MSD) will be given on day 2 or day 3 of menstrual cycle for 5 days. The
starting dose is individualized for each patient based on the following criteria: AMH <0.7
ng/mL, dose 300 IU/day; AMH 0.7-2.1 ng/mL, dose 200 IU/day; AMH >2.1 ng/mL, dose 150 IU/day.
After that, investigators can titrate the dose based on their clinical judgment. Follicular
development will be monitored by ultrasound scanning and measurement of estradiol and
progesterone levels, starting on day 5 of stimulation. Scanning and hormonal measurement will
be repeated every 2 to 3 days, depending on the size of follicles. An antagonist is routinely
used on day 5 until the day of triggering. Criteria for triggering, by hCG (Ovitrelle 250 mg,
Merck, Germany) will be the presence of at least three leading follicles of 17 mm. In women
with excessive follicular response (≥15 follicles ≥12 mm), 0,2 mg Triptorelin (Diphereline,
Ipsen Beaufour, France) will be used when there are at least two leading follicles of 17 mm.
Oocyte retrieval will be performed 36 hours after triggering.
Randomization and allocation of participants to study groups will be performed on the day of
egg pick up, after having obtained the semen from the husband. Eligible participants that
have provided informed consent will be randomised to either ICSI or conventional IVF.
In ICSI group, insemination will be performed by using ICSI, 3 - 4 hours after oocyte
retrieval. OCCs will be stripped by using hyaluronidase. Only matured oocytes will be
inseminated.
In conventional IVF group, insemination will be performed by conventional IVF. Two hours
after retrieval, collected OCCs will be inseminated for another 2 hours, at a concentration
of 100,000 motile sperm/ml. Inseminated OCCs will be cultured overnight in culture medium.
In both groups, fertilization check will be performed under inverted microscope at period of
16-18 hours after insemination. On day 3, embryo evaluation will be performed at fixed time
point 66±2 hours after fertilization, using the Istanbul consensus. Embryo transfer will be
performed on day 3 under ultrasound guidance. A maximum of 2 embryos will be transferred into
the uterus. The remaining grade 1 and 2 embryos will be frozen. Luteal-phase support will be
done with estradiol (Valiera 2mg) 8mg/day and vaginal progesterone 800mg/day (Cyclogest
400mg) until 7th week of gestation.
If there are contra-indications for fresh embryo transfer, a freeze-all strategy will be
applied, using Cryotech technique. Indications for freeze-all include: risk of ovarian
hyperstimulation syndrome (OHSS), premature progesterone rise (≥1.5 ng/ml), thin endometrium
(<7 mm), fluid in cavity on day of embryo transfer, endometrial polyp, hydrosalpinx that have
not removed before oocyte retrieval.
In the next cycle, endometrium will be prepared by using estradiol (Valiera 2 mg, 8 mg/day)
orally, starting from day 2-3 of menstrual cycle. When the endometrium thickness reaches 8 mm
or more, patients will start using progesterone vaginally (Cyclogest 400 mg, 800 mg/day).
Embryo transfer will be performed 3 days after using progesterone. On the day of embryo
transfer, embryos will be thawed. In the frozen/thawed cycle, the best embryos will be
utilized first, as in fresh transfer. Two hours after thawing, a maximum of 2 surviving
embryos will be transferred into the uterus under ultrasound guidance. Luteal phase support
will be provided with estradiol (Valiera 2mg) 8mg/day and vaginal progesterone 800 mg/day
(Cyclogest 400 mg) until the seventh week of gestation.
In both groups, clinicians who perform embryo transfer, either fresh or frozen cycles, will
be blinded to the intervention.
A serum hCG will be measured 2 weeks after embryo transferred, and if positive, an ultrasound
scan of the uterus will be performed at gestational weeks 7 and 12. At 11 - 12 weeks of
gestation, participants will be referred to the Outpatient clininc, O&G Department, My Duc
hospital or An Sinh hospital for prenatal care until giving birth.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03607409 -
Role of Inhibin A as Biomarker for Ovarian Response for IVF Treatment
|
||
Recruiting |
NCT02312076 -
GnRHa for Luteal Phase Support in Long GnRHa Protocol Cycles
|
Phase 4 | |
Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
Completed |
NCT03287479 -
Comparison of a Semi-automated Closed Vitrification System (Gavi®) With a Manual Open Vitrification Sytem (Cryotop®)
|
N/A | |
Terminated |
NCT03522350 -
Randomized Trial Comparing EmbryoScope With EmbryoScope+.
|
N/A | |
Completed |
NCT04496284 -
Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen
|
N/A | |
Completed |
NCT03623659 -
pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts
|
N/A | |
Completed |
NCT03895099 -
New Ovarian Stimulation With Random Start, Use of Progestin Protocol for Oocyte Donors
|
Phase 3 | |
Active, not recruiting |
NCT04142112 -
Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation
|
N/A | |
Completed |
NCT03152643 -
Cumulative Live Birth Rates After Cleavage-stage Versus Blastocyst-stage Embryo Transfer
|
N/A | |
Recruiting |
NCT03683771 -
Assessment of Endometrial Pattern and Sub-endometrial Vascularity in ICSI Outcome
|
||
Recruiting |
NCT03161119 -
Comparing Two Different Embryo Transfer Catheters
|
N/A | |
Completed |
NCT04108039 -
Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles.
|
N/A | |
Completed |
NCT03677492 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD)
|
N/A | |
Completed |
NCT03678558 -
Oocyte Vitrification Aided With Cytochalasin B
|
N/A | |
Completed |
NCT03678818 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin A (ICSI-LA)
|
N/A | |
Completed |
NCT03678571 -
Oocyte Vitrification Aided With Latrunculin A
|
N/A | |
Completed |
NCT03678597 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)
|
N/A | |
Completed |
NCT03678584 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)
|
N/A | |
Completed |
NCT03678610 -
Handling Medium for ICSI With Ionomycin and Latrunculin A
|
N/A |