Table 5. Open in new tab Pregnancy, live...

	GnRH agonist protocol	GnRH antagonist protocol	Estimated difference (95% CI) and P-value
Positive βhCG test	91 (45.0)	79 (38.7)	6.99 (−2.71; 16.70)
P = 0.1579^a
Ongoing pregnancies
Ongoing pregnancy (all participants) per started cycle (multiple imputations)	73 (36.1)	60 (29.4)	7.74 (−1.49; 16.97)
P = 0.1002^a
Singleton	69	60	–
Twins	4	1
Ongoing pregnancy per started cycle in low AMH (<15 pmol/l) subgroup	31 (36.9)	32 (33.0)	_
[n = 92]	[n = 102]
Ongoing pregnancy per started cycle in high AMH (15–35 pmol/l) subgroup	42 (35.6)	28 (26.2)	_
[n = 128]	[n = 113]
Ongoing pregnancy rate per transfer	42.7%	35.9%	–
Participants with live birth (per started cycle)	71 (35.1)	59 (28.9)	7.15 (−2.02; 16.31)
P = 0.1265^a
Participants with live neonate(s) at 4 weeks after birth (per started cycle)	70 (34.7)	59 (28.9)	6.59 (−2.56; 15.73)
P = 0.1580^a
Number of live neonates at birth, n	75	60	–
Singletons, n	67	58	–
Twins, n	8	2	–
Live neonates at 4 weeks, n	73	60	–
Singletons, n	67	58	–
Twins, n	6^b	2	–
*Neonatal outcomes at birth*
Gestational age, weeks	38.9 ± 3.02	39.6 ± 1.81	–
Birthweight, g	3294 ± 740	3376 ± 607	–
Apgar scores
1 min	8.4 ± 1.5	8.6 ± 1.4	–
5 min	9.5 ± 0.7	9.4 ± 1.1	–
10 min	9.8 ± 0.5	9.7 ±0.7	–
Admissions to NICU	10 (13.3)	6 (10.0)	–
Congenital malformation	2 (2.7)	2 (3.3)	–
Heart malformation	1 (1.3)	1 (1.7)	–
Foot malformation	1 (1.3)	1 (1.7)	–

GnRH agonist protocol

GnRH antagonist protocol

Estimated difference (95% CI) and P-value

n = 202

n = 204

Positive βhCG test

91 (45.0)

79 (38.7)

6.99 (−2.71; 16.70)

P = 0.1579^a

Ongoing pregnancies

Ongoing pregnancy (all participants) per started cycle (multiple imputations)

73 (36.1)

60 (29.4)

7.74 (−1.49; 16.97)

P = 0.1002^a

Singleton

–

Twins

Ongoing pregnancy per started cycle in low AMH (<15 pmol/l) subgroup

31 (36.9)

32 (33.0)

[n = 92]

[n = 102]

Ongoing pregnancy per started cycle in high AMH (15–35 pmol/l) subgroup

42 (35.6)

28 (26.2)

[n = 128]

[n = 113]

Ongoing pregnancy rate per transfer

42.7%

35.9%

–

Participants with live birth (per started cycle)

71 (35.1)

59 (28.9)

7.15 (−2.02; 16.31)

P = 0.1265^a

Participants with live neonate(s) at 4 weeks after birth (per started cycle)

70 (34.7)

59 (28.9)

6.59 (−2.56; 15.73)

P = 0.1580^a

Number of live neonates at birth, n

–

Singletons, n

–

Twins, n

–

Live neonates at 4 weeks, n

–

Singletons, n

–

Twins, n

6^b

–

Neonatal outcomes at birth

Gestational age, weeks

38.9 ± 3.02

39.6 ± 1.81

–

Birthweight, g

3294 ± 740

3376 ± 607

–

Apgar scores

1 min

8.4 ± 1.5

8.6 ± 1.4

–

5 min

9.5 ± 0.7

9.4 ± 1.1

–

10 min

9.8 ± 0.5

9.7 ±0.7

–

Admissions to NICU

10 (13.3)

6 (10.0)

–

Congenital malformation

2 (2.7)

2 (3.3)

–

Heart malformation

1 (1.3)

1 (1.7)

–

Foot malformation

1 (1.3)

1 (1.7)

–

	GnRH agonist protocol	GnRH antagonist protocol	Estimated difference (95% CI) and P-value
Positive βhCG test	91 (45.0)	79 (38.7)	6.99 (−2.71; 16.70)
P = 0.1579^a
Ongoing pregnancies
Ongoing pregnancy (all participants) per started cycle (multiple imputations)	73 (36.1)	60 (29.4)	7.74 (−1.49; 16.97)
P = 0.1002^a
Singleton	69	60	–
Twins	4	1
Ongoing pregnancy per started cycle in low AMH (<15 pmol/l) subgroup	31 (36.9)	32 (33.0)	_
[n = 92]	[n = 102]
Ongoing pregnancy per started cycle in high AMH (15–35 pmol/l) subgroup	42 (35.6)	28 (26.2)	_
[n = 128]	[n = 113]
Ongoing pregnancy rate per transfer	42.7%	35.9%	–
Participants with live birth (per started cycle)	71 (35.1)	59 (28.9)	7.15 (−2.02; 16.31)
P = 0.1265^a
Participants with live neonate(s) at 4 weeks after birth (per started cycle)	70 (34.7)	59 (28.9)	6.59 (−2.56; 15.73)
P = 0.1580^a
Number of live neonates at birth, n	75	60	–
Singletons, n	67	58	–
Twins, n	8	2	–
Live neonates at 4 weeks, n	73	60	–
Singletons, n	67	58	–
Twins, n	6^b	2	–
*Neonatal outcomes at birth*
Gestational age, weeks	38.9 ± 3.02	39.6 ± 1.81	–
Birthweight, g	3294 ± 740	3376 ± 607	–
Apgar scores
1 min	8.4 ± 1.5	8.6 ± 1.4	–
5 min	9.5 ± 0.7	9.4 ± 1.1	–
10 min	9.8 ± 0.5	9.7 ±0.7	–
Admissions to NICU	10 (13.3)	6 (10.0)	–
Congenital malformation	2 (2.7)	2 (3.3)	–
Heart malformation	1 (1.3)	1 (1.7)	–
Foot malformation	1 (1.3)	1 (1.7)	–

Table 5.

Open in new tab

Pregnancy, live birth, and neonatal outcomes (safety analysis set).

	GnRH agonist protocol	GnRH antagonist protocol	Estimated difference (95% CI) and P-value
	n = 202	n = 204	Estimated difference (95% CI) and P-value
Positive βhCG test	91 (45.0)	79 (38.7)	6.99 (−2.71; 16.70)
Positive βhCG test	91 (45.0)	79 (38.7)	P = 0.1579^a
Ongoing pregnancies
Ongoing pregnancy (all participants) per started cycle (multiple imputations)	73 (36.1)	60 (29.4)	7.74 (−1.49; 16.97)
	73 (36.1)	60 (29.4)	P = 0.1002^a
Singleton	69	60	–
Twins	4	1
Ongoing pregnancy per started cycle in low AMH (<15 pmol/l) subgroup	31 (36.9)	32 (33.0)	_
	[n = 92]	[n = 102]	_
Ongoing pregnancy per started cycle in high AMH (15–35 pmol/l) subgroup	42 (35.6)	28 (26.2)	_
	[n = 128]	[n = 113]	_
Ongoing pregnancy rate per transfer	42.7%	35.9%	–
Participants with live birth (per started cycle)	71 (35.1)	59 (28.9)	7.15 (−2.02; 16.31)
Participants with live birth (per started cycle)	71 (35.1)	59 (28.9)	P = 0.1265^a
Participants with live neonate(s) at 4 weeks after birth (per started cycle)	70 (34.7)	59 (28.9)	6.59 (−2.56; 15.73)
	70 (34.7)	59 (28.9)	P = 0.1580^a
Number of live neonates at birth, n	75	60	–
Singletons, n	67	58	–
Twins, n	8	2	–
Live neonates at 4 weeks, n	73	60	–
Singletons, n	67	58	–
Twins, n	6^b	2	–
*Neonatal outcomes at birth*
Gestational age, weeks	38.9 ± 3.02	39.6 ± 1.81	–
Birthweight, g	3294 ± 740	3376 ± 607	–
Apgar scores
1 min	8.4 ± 1.5	8.6 ± 1.4	–
5 min	9.5 ± 0.7	9.4 ± 1.1	–
10 min	9.8 ± 0.5	9.7 ±0.7	–
Admissions to NICU	10 (13.3)	6 (10.0)	–
Congenital malformation	2 (2.7)	2 (3.3)	–
Heart malformation	1 (1.3)	1 (1.7)	–
Foot malformation	1 (1.3)	1 (1.7)	–

	GnRH agonist protocol	GnRH antagonist protocol	Estimated difference (95% CI) and P-value
	n = 202	n = 204	Estimated difference (95% CI) and P-value
Positive βhCG test	91 (45.0)	79 (38.7)	6.99 (−2.71; 16.70)
Positive βhCG test	91 (45.0)	79 (38.7)	P = 0.1579^a
Ongoing pregnancies
Ongoing pregnancy (all participants) per started cycle (multiple imputations)	73 (36.1)	60 (29.4)	7.74 (−1.49; 16.97)
	73 (36.1)	60 (29.4)	P = 0.1002^a
Singleton	69	60	–
Twins	4	1
Ongoing pregnancy per started cycle in low AMH (<15 pmol/l) subgroup	31 (36.9)	32 (33.0)	_
	[n = 92]	[n = 102]	_
Ongoing pregnancy per started cycle in high AMH (15–35 pmol/l) subgroup	42 (35.6)	28 (26.2)	_
	[n = 128]	[n = 113]	_
Ongoing pregnancy rate per transfer	42.7%	35.9%	–
Participants with live birth (per started cycle)	71 (35.1)	59 (28.9)	7.15 (−2.02; 16.31)
Participants with live birth (per started cycle)	71 (35.1)	59 (28.9)	P = 0.1265^a
Participants with live neonate(s) at 4 weeks after birth (per started cycle)	70 (34.7)	59 (28.9)	6.59 (−2.56; 15.73)
	70 (34.7)	59 (28.9)	P = 0.1580^a
Number of live neonates at birth, n	75	60	–
Singletons, n	67	58	–
Twins, n	8	2	–
Live neonates at 4 weeks, n	73	60	–
Singletons, n	67	58	–
Twins, n	6^b	2	–
*Neonatal outcomes at birth*
Gestational age, weeks	38.9 ± 3.02	39.6 ± 1.81	–
Birthweight, g	3294 ± 740	3376 ± 607	–
Apgar scores
1 min	8.4 ± 1.5	8.6 ± 1.4	–
5 min	9.5 ± 0.7	9.4 ± 1.1	–
10 min	9.8 ± 0.5	9.7 ±0.7	–
Admissions to NICU	10 (13.3)	6 (10.0)	–
Congenital malformation	2 (2.7)	2 (3.3)	–
Heart malformation	1 (1.3)	1 (1.7)	–
Foot malformation	1 (1.3)	1 (1.7)	–

Primary analysis was based on all randomized subjects using a multiple imputation method for randomized subjects withdrawing before start of stimulation but did not include subjects who had cycle cancellation due to logistical reasons related to the COVID-19 pandemic (GnRH agonist group: n = 217; GnRH antagonist group: n = 214).

There were two neonatal deaths in the GnRH agonist group—a set of monochorionic twins born at gestational age 24 weeks+2 days died shortly after birth due to prematurity.

Data are mean±SD or n (%) unless stated otherwise.

AMH, anti-Müllerian hormone; NICU, neonatal intensive care unit.

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