Protocol summary

Summary
In a randomized clinical trial of patients referred to Avicenna Infertility Center, we will compare double trigger by GnRh agonist along with HCG versus HCG alone in improving the ART results. After considering the including criteria and receiving appropriate consents, patients are enrolled in the trial. The antagonist cycle begins as Flexible Step Up protocol. When at least two follicles larger than 17 or 18 mm are seen, patients will be divided into two groups based on computerized randomization. The first group receives HCG 10,000 units alone and the other group receives 10,000 units HGC plus 0.2 mg of Decapetyl subcutaneously. All of the oocytes are punctured under sonographic guidance 36 hours after the trigger. After 72 hours, 2 to 3 embryos will be transferred to the uterus and the rest will be frozen. After the puncture, progesterone will be prescribed for luteal phase support. On the third day after trigger and puncture, estradiol, LH, FSH and progesterone levels will be measured and so will the endometrial thickness. BHGC test will be performed and if the pregnancy test is positive, it would be considered a chemical pregnancy. Two weeks after a positive pregnancy test, transvaginal sonography will be performed to check the gestational sac. By detecting FHR in the sonogram clinical pregnancy is confirmed. Then the study will progress till 12th week and a sonography will be done to check the FHR and fetal health and to rule out abortion. These variables will be compared in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017091736235N1
Registration date: 2017-11-05, 1396/08/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-11-05, 1396/08/14
Registrant information
Name
Niloofar Motaref
Name of organization / entity
Avicenna Infertility And Recurrent Abortion Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 23519
Email address
n.motaref@avicenna.ac.ir
Recruitment status
Recruitment complete
Funding source
Avicenna Infertility and Abortion Research Institute
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the outcomes of dual trigger with GnRh agonist along with HCG versus HCG alone in normal responder patients in antagonist ART protocol
Public title
The effect of using HCG in combination with the GnRh agonist for improving IVF outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Infertility due to male factor, tubal factor or unexplained; IVF less than 2 times; age between 18 and 40; BMI between 18 and 30; normal PRL and TSH; FSH less than 10; The minimum sperm count, 10 million and the minimum 3% of the sperms should have normal morphology. Exclusion criteria: AFC more than 15; E2 more than 3000 at trigger day or AFC more than 20; sensitization to HCG or gonadotropins; FSH more than 10 at third day of cycles or AFC less than 5; AUB; documented uterine anomaly in hysterogram or HSG; endometriosis (grade 3 and 4); Diabetes or uncontrolled HTN, kidney or liver dysfunction; PCO; Cancer, tumor, or pituitary adenoma; Ovarian cysts; hydrosalpinx; intramural or submucosal myoma larger than 6cm
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 164
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Avicenna Research Institute Ethics Commitee
Street address
Avicenna Research Institute, Shahid Beheshti University, Velenjak Avenue, Chamran highway
City
Tehran
Postal code
1941913114
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.ACECR.Avicenna.REC.1396.14

Health conditions studied

1

Description of health condition studied
infertility
ICD-10 code
N97.9
ICD-10 code description
female infertility

Primary outcomes

1

Description
Clinical pregnancy
Timepoint
28 days after transfer
Method of measurement
vaginal sonography

Secondary outcomes

1

Description
Chemical pregnancy rate
Timepoint
14 days after transfer
Method of measurement
BHCG test

2

Description
Number of embryo formation
Timepoint
3 days after pancture
Method of measurement
Number

3

Description
OHSS
Timepoint
Till 2 weeks after ET
Method of measurement
sonography and symptoms

4

Description
Abortion
Timepoint
6th and 12th week of pregnancy
Method of measurement
sonography

5

Description
Number of oocyte (2PN)
Timepoint
Puncture day
Method of measurement
Number

Intervention groups

1

Description
Control group will receive 10000 unit HCG for triggering final oocyte maturation
Category
Treatment - Drugs

2

Description
Intervention group will receive 10000 unit HCG pluse 0.2 mg decapeptyle for final maturation of oocyte
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Avicenna Infertility And Recurrent Abortion Research Institute
Full name of responsible person
Dr.Sara Mokhtar
Street address
No. 97, Yakhchal Junction, Shariati St
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Avicenna Research Institute
Full name of responsible person
Dr Seyed Ali Azin
Street address
Avicenna Research Institute, Shahid Beheshti University; Velenjak, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Avicenna Research Institute
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Avicenna Infertility And Recurrent Abortion Research Institute
Full name of responsible person
Dr Sara Mokhtar
Position
MD, OB&GYN, Infertility fellowship
Other areas of specialty/work
Street address
No. 97, Yakhchal Junction, Shariati St.
City
Tehran
Postal code
1941913114
Phone
+98 21 23519
Fax
+98 21 2264 4754
Email
Smkhtr@yahoo.com
Web page address
https://www.avic.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Avicenna Infertility And Recurrent Aborton Research Institute
Full name of responsible person
Dr Zhaleh Zolghadri
Position
MD, OB&GYN, Infertility fellowship
Other areas of specialty/work
Street address
No. 97, Yakhchal Junction, Shariati St
City
Tehran
Postal code
1941913114
Phone
+98 21 23519
Fax
+98 21 2264 4754
Email
jzolghadr@yahoo.com
Web page address
https://www.avic.ir

Person responsible for updating data

Contact
Name of organization / entity
Avicenna Infertility And Recurrent Abortion Research Institute
Full name of responsible person
Niloofar Motaref
Position
MD, OB&GYN, Assistant Infertility Fellowship
Other areas of specialty/work
Street address
No. 97, Yakhchal Junction, Shariati St
City
Tehran
Postal code
1941913114
Phone
+98 21 23519
Fax
+98 22644754
Email
niloofar_motaref@yahoo.com;n.motaref@yahoo.com
Web page address
https://www.avic.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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